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InstruSafe

EUDAMEDFDA UDI

Class I (EU MDR)

Ref IN-2020-0126Ref IN-2020-0261Ref IN-2020-1192Ref IN-2020-1204Ref IN-2020-1276Ref IN-2020-1175Ref IN-2020-0288Ref IN-2020-0307Ref IN-2020-1285Ref IN-2020-0523Ref IN-2020-0673Ref IN-2020-0789Ref IN-2020-1099Ref IN-2020-0636Ref IN-2020-1263Ref IN-2020-0520Ref IN-2020-0617Ref IN-2020-3223Ref IN-2020-0672Ref IN-2020-0128Ref IN-2020-3647Ref IN-2020-0596Ref IN-2020-2278Ref IN-2020-0909Ref IN-2020-1239Ref IN-2020-1124Ref IN-2020-2912Ref IN-2020-1203Ref IN-2020-0125Ref IN-2020-0751Ref IN-2020-0334Ref IN-2020-1161Ref IN-2020-1258Ref IN-2020-1193Ref IN-2020-1137Ref IN-2020-0782Ref IN-2020-0190Ref IN-2020-0852Ref IN-2020-0831Ref IN-2020-1463Ref IN-2020-0457Ref IN-2020-1088Ref IN-2020-0939Ref IN-2020-0793Ref IN-2020-0816Ref IN-2020-0393Ref IN-2020-0988Ref IN-2020-0108Ref IN-2020-0118Ref IN-2020-0647Ref IN-2020-0607Ref IN-2020-0472Ref IN-2020-0499Ref IN-2020-0351Ref IN-2020-3064Ref IN-2020-0976Ref IN-2020-0367Ref IN-2020-1227Ref IN-2020-0280Ref IN-2020-0562Ref IN-2020-1207Ref IN-2020-0745Ref IN-2020-1611Ref IN-2020-0432Ref IN-2020-0314Ref IN-2020-0954Ref IN-2020-0379Ref IN-2020-0743Ref IN-2020-0338Ref IN-2020-1311Ref IN-2020-0117Ref IN-2020-0612Ref IN-2020-0133Ref IN-2020-0166Ref IN-2020-1030Ref IN-2020-0679Ref IN-2020-0541Ref IN-2020-0486Ref IN-2020-1248Ref IN-2020-0755Ref IN-2020-0955Ref IN-2020-0912Ref IN-2020-1131Ref IN-2020-2009Ref IN-2020-0921Ref IN-2020-0205Ref IN-2020-3068Ref IN-2020-1274Ref IN-2020-1142Ref IN-2020-0403Ref IN-2020-1226Ref IN-2020-1312Ref IN-2020-2990Ref IN-2020-0907Ref IN-2020-0144Ref IN-2020-0426Ref IN-2020-0915Ref IN-2020-0348Ref IN-2020-0756Ref IN-2020-0270Ref IN-2020-0433Ref IN-2020-1108Ref IN-2020-0665Ref IN-2020-1024Ref IN-2020-0965Ref IN-2020-0838Ref IN-2020-0538Ref IN-2020-0945Ref IN-2020-0100Ref IN-2020-0926Ref IN-2020-0599Ref IN-2020-0247Ref IN-2020-0449Ref IN-2020-0311Ref IN-2020-0691Ref IN-2020-1112Ref IN-2020-0518Ref IN-2020-0103Ref IN-2020-0511Ref IN-2020-0407Ref IN-2020-1317Ref IN-2020-0634Ref IN-2020-0771Ref IN-2020-0106Ref IN-2020-0460Ref IN-2020-0987Ref IN-2020-2220Ref IN-2020-0483Ref IN-2020-4288Ref IN-2020-0677Ref IN-2020-1176Ref IN-2020-1217Ref IN-2020-1219Ref IN-2020-1178Ref IN-2020-0936Ref IN-2020-0974Ref IN-2020-0786Ref IN-2020-1010Ref IN-2020-1310Ref IN-2020-0809Ref IN-2020-0916Ref IN-2020-1218Ref IN-2020-0725Ref IN-2020-0352Ref IN-2020-0222Ref IN-8931-RRef IN-2020-0240Ref IN-2020-0605Ref IN-2020-0097Ref IN-2020-0323Ref IN-2020-0911Ref IN-2020-0966Ref IN-2020-1232Ref IN-2020-1138Ref IN-2020-0152Ref IN-2020-0552Ref IN-2020-0268Ref IN-2020-0732Ref IN-2020-0161Ref IN-2020-0391Ref IN-2020-0557Ref IN-2020-0946Ref IN-2020-0723Ref IN-2020-0642Ref IN-2020-0251Ref IN-2020-0215Ref IN-2020-0600Ref IN-2020-1092Ref IN-2020-3030Ref IN-2020-0854Ref IN-2020-0544Ref IN-2020-0676Ref IN-2020-0458Ref IN-2020-2754Ref IN-2020-3228Ref IN-2020-0175Ref IN-2020-0649Ref IN-2020-1213Ref IN-2020-0395Ref IN-2020-0919Ref IN-2020-0381Ref IN-2020-0305Ref IN-2020-0370Ref IN-2020-0491Ref IN-2020-1223Ref IN-2020-1082Ref 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IN-2020-0702Ref IN-2020-0621Ref IN-2020-1113Ref IN-2020-0359Ref IN-2020-0800Ref IN-2020-0855Ref IN-2020-0357Ref IN-2020-0347Ref IN-2020-0639Ref IN-2020-0577Ref IN-2020-1202Ref IN-2020-1283Ref IN-2020-0444Ref IN-2020-1273Ref IN-2020-1105Ref IN-2020-0709Ref IN-2020-0527Ref IN-2020-0740Ref IN-2020-0746Ref IN-2020-0695Ref IN-2020-1513Ref IN-2020-0163Ref IN-2020-0830Ref IN-2020-0615Ref IN-2020-0263Ref IN-2020-0651Ref IN-2020-0614Ref IN-2020-0154Ref IN-2020-0801Ref IN-2020-0221Ref IN-2020-1164Ref IN-2020-0401Ref IN-2020-0900Ref IN-2020-0758Ref IN-2020-0817Ref IN-2020-0434Ref IN-2020-0738Ref IN-2020-0109Ref IN-2020-0176Ref IN-2020-0542Ref IN-2020-0469Ref IN-2020-0536Ref IN-2020-1144Ref IN-2020-0148Ref IN-2020-0627Ref IN-2020-0822Ref IN-2020-1014Ref IN-2020-1448Ref IN-2020-0482Ref IN-2020-0986Ref IN-2020-0211Ref IN-2020-0949Ref IN-2020-0364Ref IN-2020-0509Ref IN-2020-0739Ref IN-2020-0865Ref IN-2020-1126Ref IN-2020-0572Ref IN-2020-0993Ref IN-2020-0187Ref IN-2020-0752Ref IN-2020-1796Ref IN-2020-0630Ref IN-2020-3342Ref IN-2020-0198Ref IN-2020-0684Ref IN-2020-0943Ref IN-2020-0877Ref IN-2020-0436Ref IN-2020-1319Ref IN-2020-0315Ref IN-2020-0704Ref IN-2020-0245Ref IN-2020-1139Ref IN-2020-0610Ref IN-2020-0528Ref IN-2020-0207Ref IN-2020-0741Ref IN-2020-0387Ref IN-2020-0385Ref IN-2020-0375Ref IN-2020-1752Ref IN-2020-1020Ref IN-2020-0451Ref IN-2020-0682Ref IN-2020-0402Ref IN-2020-1003Ref IN-2020-0530Ref IN-2020-1037Ref IN-2020-0112Ref IN-2020-0476Ref IN-2020-0670Ref IN-2020-0776Ref IN-2020-1221Ref IN-2020-0256Ref IN-2020-0300Ref IN-2020-0343Ref IN-2020-0257Ref IN-2020-0583Ref IN-2020-0579Ref IN-2020-0355Ref IN-2020-0981Ref IN-2020-0445Ref IN-2020-0193Ref IN-2020-1229Ref IN-2020-0203Ref IN-2020-1253Ref IN-2020-3525Ref IN-2020-1252Ref IN-2020-0978Ref IN-2020-0423Ref IN-2020-1006Ref IN-2020-0259Ref IN-2020-0453Ref IN-2020-0773Ref IN-2020-1280Ref IN-2020-0566Ref IN-2020-0812Ref IN-2020-1106Ref IN-2020-1674Ref IN-2020-0553Ref IN-2020-0629Ref IN-2020-3825Ref IN-3030-0090Ref IN-7260-TFRef IN-2020-3472Ref IN-2020-2174Ref IN-2020-2680Ref INS-7008-RRef IN-3030-0151Ref IN-2020-0582Ref IN-2020-2282Ref IN-2020-2904Ref OM-8782-RRef IN-2020-0336Ref IN-2020-1085Ref IN-2020-0191Ref IN-2020-1220Ref IN-2020-0724Ref IN-3030-0117Ref IN-2020-2198Ref IN-2020-2755Ref IN-7323-RRef INS-8915-TFRef IN-7835-TFRef IN-2020-0940Ref IN-2020-3638Ref IN-2020-1038Ref IN-2020-0790Ref IN-3030-0195Ref IN-2020-1404Ref IN-2020-3039Ref IN-7430-RRef IN-8823-CFRef IN-2020-1255Ref IN-5401Ref IN-2020-3266Ref IN-3030-0066Ref OM-4626-FTRef IN-2020-0875Ref IN-2020-0168Ref IN-2020-0344Ref INS-8916-NFRef IN-2020-2988Ref IN-2020-2035Ref IN-2020-3932Ref IN-2020-2744Ref IN-2020-2182Ref IN-2020-1365Ref IN-2020-1901Ref IN-2020-0767Ref IN-2020-0164Ref IN-2020-3133Ref IN-2020-1027Ref IN-8742-TFRef IN-2020-1451Ref OM-7840-MLRef IN-2020-0942Ref IN-2020-0551Ref IN-2020-3297Ref IN-2020-0584Ref IN-2020-2144Ref IN-2020-2824Ref IN-2020-0944Ref IN-2300-06Ref IN-8750-TFRef IN-2020-0693Ref IN-2020-0960Ref IN-7010-PFRef IN-2672Ref IN-2020-1737Ref IN-3030-0134Ref IN-2020-2668Ref IN-2020-0645Ref IN-2020-1120Ref IN-4912Ref IN-2020-1694Ref IN-5030-NFRef IN-2020-4161Ref IN-2020-0872Ref OM-1001-SBRef IN-2020-0880Ref IN-7837-NFRef IN-7160-TFRef IN-8764-TFRef IN-3030-0016Ref IN-2020-2914Ref IN-2020-3539Ref INS-7223-TFRef IN-2020-0638Ref IN-6810Ref IN-2020-0992Ref IN-3030-0106Ref IN-7644-TFRef IN-2020-0467Ref INS-8921-NFRef IN-2020-3112Ref IN-3030-0063Ref IN-5030-RRef IN-2020-2641Ref OM-1001-PT-06Ref IN-3030-0178Ref IN-2020-0882Ref INS-8921-TFRef IN-2020-4059Ref IN-8741-NFRef IN-2020-0083Ref IN-2020-1892Ref IN-2020-3282Ref INS-7223-RRef IN-2020-0864Ref IN-2020-0260Ref IN-2020-0927Ref IN-2020-3938Ref IN-2020-1836Ref IN-2020-2022Ref IN-2020-0708Ref IN-8899-NFRef IN-2020-3320Ref IN-5040-RRef IN-2020-1941Ref IN-4830Ref IN-2020-1861Ref IN-3970Ref IN-2020-1765Ref IN-7473-RRef OM-8791-RRef IN-2020-1230Ref IN-2020-0389Ref IN-7582-RRef IN-2020-0177Ref IN-2020-6170Ref IN-2020-1807Ref IN-2020-0373Ref IN-2020-1236Ref IN-2020-3398Ref IN-2020-1122Ref IN-3030-0088Ref IN-7030-NFRef IN-8946-RRef IN-2020-4099Ref IN-2020-1114Ref IN-2020-0898Ref OM-1004-SBRef IN-2020-3765Ref IN-2020-0162Ref OM-1000-TNRef IN-2020-0086Ref INS-7274-RRef INS-7223-NFRef IN-2020-1691Ref IN-2020-0396Ref IN-2020-2263Ref IN-7454-NFRef IN-2020-3575Ref IN-2020-1486Ref IN-3030-0111Ref IN-2020-0885Ref IN-2020-1936Ref IN-7250-NFRef IN-2020-0532Ref IN-2020-0893Ref IN-2020-3715Ref IN-2707Ref INS-8948-NFRef IN-3030-0032Ref IN-2020-0255Ref IN-PIC-20-DRef IN-2020-4333Ref IN-7783-NFRef IN-6022-NFRef IN-8764-RRef IN-2020-0869Ref IN-2647Ref IN-7078-NFRef IN-7454-TFRef IN-2020-1843Ref IN-2020-2774Ref IN-3030-0113Ref IN-2020-0327Ref IN-8983-TFRef IN-2020-2977Ref IN-2020-1334Ref IN-3030-0139Ref IN-2020-1568Ref IN-2020-0868Ref IN-2020-1044Ref IN-2300-04Ref IN-2020-2859Ref IN-2020-3043Ref IN-7360-NFRef IN-2020-2552Ref IN-2300-08Ref IN-2020-1130Ref IN-2020-0016Ref IN-2020-0881Ref IN-2020-1272Ref IN-2020-0461Ref IN-2020-2325Ref IN-2020-1846Ref IN-2020-2630Ref IN-8939-TFRef IN-2020-1676Ref IN-2020-2933Ref IN-3030-0180Ref IN-2020-1225Ref IN-7008-NFRef IN-2020-1743Ref IN-3030-0100Ref IN-6917Ref IN-2020-3905Ref IN-2020-0692Ref IN-2020-2803Ref INS-7008-NFRef IN-7274-NFRef IN-8743-RRef IN-2020-1437Ref IN-3030-0203Ref IN-8742-NFRef IN-2020-2504Ref IN-1411Ref IN-2020-0394Ref IN-2020-0726Ref IN-3030-0212Ref IN-2020-4034Ref IN-2020-1339Ref INS-8932-NFRef IN-2020-0934Ref IN-2020-0947Ref IN-2020-3349Ref INS-8937-RRef IN-2020-1653Ref IN-2020-1910Ref IN-8898-01-NFRef IN-8660-RRef IN-2020-3038Ref IN-2020-0021Ref IN-2020-2558Ref IN-2020-1498Ref IN-3030-0202Ref IN-3030-0138Ref IN-2600-04Ref INS-8913-TFRef IN-2020-4366Ref IN-2020-3584Ref IN-2020-1914Ref IN-2020-3624Ref IN-2020-1397Ref IN-2020-4054Ref IN-2020-3534Ref IN-3030-0169Ref IN-7430-TFRef IN-2020-0093Ref IN-8921-TFRef IN-2020-3302Ref IN-2020-0697Ref IN-2020-0895Ref IN-2020-3137Ref IN-2020-0145Ref IN-2020-2452Ref IN-2020-0540Ref IN-2020-3563Ref IN-2020-0167Ref IN-2020-2477Ref IN-2020-0759Ref IN-6906Ref IN-2020-0006Ref IN-2020-3127Ref IN-2020-4369Ref IN-2020-3542Ref IN-7076-NFRef IN-2020-0961Ref IN-2020-1493Ref IN-2020-0485Ref IN-6011-NFRef IN-2020-3838Ref IN-2020-0792Ref IN-3030-0225Ref IN-2600-12-ENRef IN-6916Ref IN-2020-4045Ref IN-2020-0556Ref INS-7274-NFRef IN-2020-4157Ref OM-1000-MURef IN-2020-2389Ref IN-6022-RRef IN-2020-2209Ref IN-2020-3439Ref IN-2020-3008Ref IN-7078-RRef IN-3030-0141Ref IN-2020-0925Ref IN-2020-0923Ref OM-1000-AERef IN-2020-0326Ref IN-5040-NFRef OM-1000-SBRef IN-2020-2002Ref IN-3030-0067Ref IN-2020-1838Ref IN-2020-0287Ref IN-2020-1713Ref IN-8901-NFRef IN-8915-NFRef IN-8740-TFRef IN-2020-1876Ref IN-2020-3218Ref IN-2020-1783Ref IN-2020-3935Ref IN-3030-0083Ref IN-3030-0150Ref IN-2020-0580Ref IN-2020-0703Ref IN-7075-RRef IN-2300-01Ref IN-2020-0157Ref IN-2020-4055Ref IN-2020-4163Ref INS-8947-RRef IN-2020-2025Ref IN-3030-0218Ref IN-7835-NFRef IN-3030-0109Ref OM-1000-MXRef IN-2020-2327Ref IN-2020-0888Ref IN-2020-3118Ref IN-8630-RRef IN-2020-1393Ref IN-2020-0160Ref IN-2020-0585Ref IN-2020-1933Ref IN-7076-RRef IN-3030-0062Ref IN-2020-0883Ref IN-2020-0354Ref IN-2600-10-ENRef IN-2020-0234Ref IN-2020-1640Ref IN-2020-0408Ref IN-2020-0828Ref IN-8950-TFRef IN-2020-2115Ref IN-7453-TFRef IN-3030-0056Ref IN-2020-0548Ref IN-2020-1461Ref IN-2600-06Ref IN-2550-01Ref IN-2020-2199Ref IN-8899-RRef IN-8930-NFRef IN-6925Ref IN-3030-0108Ref IN-5017-RRef IN-2020-1531Ref IN-2020-4186Ref IN-2020-2019Ref IN-2020-2112Ref IN-2020-3122Ref IN-2020-2592Ref IN-2020-0674Ref IN-2020-0982Ref IN-2020-3511Ref IN-2020-2004Ref IN-3030-0207Ref OM-8779-SSRef IN-8904-NFRef IN-2020-0219Ref IN-8951-RRef OM-8771-SSRef IN-8944-TFRef IN-2020-2760Ref IN-2020-0380Ref IN-2020-3283Ref OM-1000-EQRef IN-2020-3037Ref IN-2020-1269Ref OM-1004-FFRef IN-2847-NFRef IN-2020-2955Ref IN-8951-NFRef IN-3030-0099Ref IN-2020-0710Ref INS-7014-TFRef IN-2600-05Ref IN-2020-2883Ref IN-3030-0216Ref IN-2020-0150Ref IN-8741-RRef IN-8742-RRef IN-2020-3209Ref IN-2020-4284Ref IN-1310-NMRef IN-2020-3448Ref IN-8740-RRef IN-8751-NFRef IN-2020-2456Ref IN-2020-1703Ref IN-7360-TFRef IN-2020-0891Ref IN-2020-1214Ref IN-3030-0078Ref IN-2020-2660Ref IN-2020-0332Ref IN-2020-0001Ref IN-2020-2464Ref IN-2020-0886Ref IN-2020-0171Ref IN-2020-2763Ref IN-2020-0696Ref IN-3030-0118Ref IN-2020-2376Ref IN-2020-3830Ref IN-2020-0464Ref IN-3030-0095Ref IN-2020-1045Ref IN-2020-4365Ref INS-8923-NFRef IN-2020-0435Ref IN-2020-1183Ref IN-2020-3803Ref IN-3030-0126Ref IN-2020-0023Ref IN-2020-0204Ref IN-2020-0002Ref IN-7140-NFRef IN-2020-0353Ref IN-2020-3621Ref IN-2020-3894Ref IN-2600-10Ref IN-2020-1290Ref IN-3030-0221Ref IN-2020-1036Ref IN-8927-RRef IN-2020-3812Ref IN-2020-3792Ref IN-2020-4345Ref IN-8960-RRef IN-2020-1119Ref IN-2020-4395Ref IN-2020-1197Ref IN-7344-NFRef IN-2009Ref IN-8932-RRef IN-2020-2589Ref IN-2020-3208Ref IN-2020-0878Ref IN-3030-0068Ref IN-3030-0197Ref IN-3030-0176Ref IN-2600-13Ref IN-2020-2620Ref IN-3030-0107Ref IN-2020-0522Ref IN-2020-1270Ref IN-2020-1351Ref OM-1003-SBRef IN-2020-0493Ref IN-3030-0128Ref IN-2020-3585Ref IN-2600-14Ref OM-1001-PT-12Ref IN-2600-12Ref IN-3030-0059Ref IN-3030-0013

by Summit Medical, LLC

Identity

Trade Name
InstruSafe EUDAMEDFDA UDI
NA FDA UDI
Instrusfae FDA UDI
Generic Name
Instrument tray, reusable FDA UDI
Device sterilization/disinfection container, reusable FDA UDI
Device Name
InstruSafe Instrument Protection System - Trays, Accessories, and Transport Containers EUDAMED
Model / Reference
IN-2020-0126 EUDAMED
IN-2020-0261 EUDAMED
IN-2020-1192 EUDAMED
IN-2020-1204 EUDAMED
IN-2020-1276 EUDAMED
IN-2020-1175 EUDAMED
IN-2020-0288 EUDAMED
IN-2020-0307 EUDAMED
IN-2020-1285 EUDAMED
IN-2020-0523 EUDAMED
IN-2020-0673 EUDAMED
IN-2020-0789 EUDAMED
IN-2020-1099 EUDAMED
IN-2020-0636 EUDAMED
IN-2020-1263 EUDAMED
IN-2020-0520 EUDAMED
IN-2020-0617 EUDAMED
IN-2020-3223 EUDAMED
IN-2020-0672 EUDAMED
IN-2020-0128 EUDAMED
IN-2020-3647 EUDAMED
IN-2020-0596 EUDAMED
IN-2020-2278 EUDAMED
IN-2020-0909 EUDAMED
IN-2020-1239 EUDAMED
IN-2020-1124 EUDAMED
IN-2020-2912 EUDAMED
IN-2020-1203 EUDAMED
IN-2020-0125 EUDAMED
IN-2020-0751 EUDAMED
IN-2020-0334 EUDAMED
IN-2020-1161 EUDAMED
IN-2020-1258 EUDAMED
IN-2020-1193 EUDAMED
IN-2020-1137 EUDAMED
IN-2020-0782 EUDAMED
IN-2020-0190 EUDAMED
IN-2020-0852 EUDAMED
IN-2020-0831 EUDAMED
IN-2020-1463 EUDAMED
IN-2020-0457 EUDAMED
IN-2020-1088 EUDAMED
IN-2020-0939 EUDAMED
IN-2020-0793 EUDAMED
IN-2020-0816 EUDAMED
IN-2020-0393 EUDAMED
IN-2020-0988 EUDAMED
IN-2020-0108 EUDAMED
IN-2020-0118 EUDAMED
IN-2020-0647 EUDAMED
IN-2020-0607 EUDAMED
IN-2020-0472 EUDAMED
IN-2020-0499 EUDAMED
IN-2020-0351 EUDAMED
IN-2020-3064 EUDAMED
IN-2020-0976 EUDAMED
IN-2020-0367 EUDAMED
IN-2020-1227 EUDAMED
IN-2020-0280 EUDAMED
IN-2020-0562 EUDAMED
IN-2020-1207 EUDAMED
IN-2020-0745 EUDAMED
IN-2020-1611 EUDAMED
IN-2020-0432 EUDAMED
IN-2020-0314 EUDAMED
IN-2020-0954 EUDAMED
IN-2020-0379 EUDAMED
IN-2020-0743 EUDAMED
IN-2020-0338 EUDAMED
IN-2020-1311 EUDAMED
IN-2020-0117 EUDAMED
IN-2020-0612 EUDAMED
IN-2020-0133 EUDAMED
IN-2020-0166 EUDAMED
IN-2020-1030 EUDAMED
IN-2020-0679 EUDAMED
IN-2020-0541 EUDAMED
IN-2020-0486 EUDAMED
IN-2020-1248 EUDAMED
IN-2020-0755 EUDAMED
IN-2020-0955 EUDAMED
IN-2020-0912 EUDAMED
IN-2020-1131 EUDAMED
IN-2020-2009 EUDAMED
IN-2020-0921 EUDAMED
IN-2020-0205 EUDAMED
IN-2020-3068 EUDAMED
IN-2020-1274 EUDAMED
IN-2020-1142 EUDAMED
IN-2020-0403 EUDAMED
IN-2020-1226 EUDAMED
IN-2020-1312 EUDAMED
IN-2020-2990 EUDAMED
IN-2020-0907 EUDAMED
IN-2020-0144 EUDAMED
IN-2020-0426 EUDAMED
IN-2020-0915 EUDAMED
IN-2020-0348 EUDAMED
IN-2020-0756 EUDAMED
IN-2020-0270 EUDAMED
IN-2020-0433 EUDAMED
IN-2020-1108 EUDAMED
IN-2020-0665 EUDAMED
IN-2020-1024 EUDAMED
IN-2020-0965 EUDAMED
IN-2020-0838 EUDAMED
IN-2020-0538 EUDAMED
IN-2020-0945 EUDAMED
IN-2020-0100 EUDAMED
IN-2020-0926 EUDAMED
IN-2020-0599 EUDAMED
IN-2020-0247 EUDAMED
IN-2020-0449 EUDAMED
IN-2020-0311 EUDAMED
IN-2020-0691 EUDAMED
IN-2020-1112 EUDAMED
IN-2020-0518 EUDAMED
IN-2020-0103 EUDAMED
IN-2020-0511 EUDAMED
IN-2020-0407 EUDAMED
IN-2020-1317 EUDAMED
IN-2020-0634 EUDAMED
IN-2020-0771 EUDAMED
IN-2020-0106 EUDAMED
IN-2020-0460 EUDAMED
IN-2020-0987 EUDAMED
IN-2020-2220 EUDAMED
IN-2020-0483 EUDAMED
IN-2020-4288 EUDAMED
IN-2020-0677 EUDAMED
IN-2020-1176 EUDAMED
IN-2020-1217 EUDAMED
IN-2020-1219 EUDAMED
IN-2020-1178 EUDAMED
IN-2020-0936 EUDAMED
IN-2020-0974 EUDAMED
IN-2020-0786 EUDAMED
IN-2020-1010 EUDAMED
IN-2020-1310 EUDAMED
IN-2020-0809 EUDAMED
IN-2020-0916 EUDAMED
IN-2020-1218 EUDAMED
IN-2020-0725 EUDAMED
IN-2020-0352 EUDAMED
IN-2020-0222 EUDAMED
IN-8931-R EUDAMED
IN-2020-0240 EUDAMED
IN-2020-0605 EUDAMED
IN-2020-0097 EUDAMED
IN-2020-0323 EUDAMED
IN-2020-0911 EUDAMED
IN-2020-0966 EUDAMED
IN-2020-1232 EUDAMED
IN-2020-1138 EUDAMED
IN-2020-0152 EUDAMED
IN-2020-0552 EUDAMED
IN-2020-0268 EUDAMED
IN-2020-0732 EUDAMED
IN-2020-0161 EUDAMED
IN-2020-0391 EUDAMED
IN-2020-0557 EUDAMED
IN-2020-0946 EUDAMED
IN-2020-0723 EUDAMED
IN-2020-0642 EUDAMED
IN-2020-0251 EUDAMED
IN-2020-0215 EUDAMED
IN-2020-0600 EUDAMED
IN-2020-1092 EUDAMED
IN-2020-3030 EUDAMED
IN-2020-0854 EUDAMED
IN-2020-0544 EUDAMED
IN-2020-0676 EUDAMED
IN-2020-0458 EUDAMED
IN-2020-2754 EUDAMED
IN-2020-3228 EUDAMED
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IN-2020-3792 EUDAMEDFDA UDI
IN-2020-2774 EUDAMEDFDA UDI
IN-2020-0582 EUDAMED
IN-2020-0336 EUDAMED
IN-2020-1085 EUDAMED
IN-2020-0191 EUDAMED
IN-2020-1220 EUDAMED
IN-2020-0724 EUDAMED
IN-2020-0940 EUDAMED
IN-2020-1038 EUDAMED
IN-2020-0790 EUDAMED
IN-2020-1255 EUDAMED
IN-2020-0875 EUDAMED
IN-2020-0168 EUDAMED
IN-2020-0164 EUDAMED
IN-2020-1027 EUDAMED
IN-2020-0551 EUDAMED
IN-2020-0584 EUDAMED
IN-2020-0944 EUDAMED
IN-2020-0693 EUDAMED
IN-2020-0960 EUDAMED
IN-2020-1737 EUDAMED
IN-2020-0645 EUDAMED
IN-2020-1120 EUDAMED
IN-2020-0880 EUDAMED
IN-2020-0638 EUDAMED
IN-2020-0992 EUDAMED
IN-2020-0467 EUDAMED
IN-2020-0882 EUDAMED
IN-2020-0864 EUDAMED
IN-2020-0927 EUDAMED
IN-2020-0708 EUDAMED
IN-2020-0389 EUDAMED
IN-2020-0177 EUDAMED
IN-2020-0373 EUDAMED
IN-2020-1114 EUDAMED
IN-2020-0898 EUDAMED
IN-2020-0162 EUDAMED
IN-2020-0396 EUDAMED
IN-2020-0885 EUDAMED
IN-2020-0532 EUDAMED
IN-2020-0327 EUDAMED
IN-2020-0868 EUDAMED
IN-2020-1044 EUDAMED
IN-2020-1130 EUDAMED
IN-2020-0881 EUDAMED
IN-2020-1272 EUDAMED
IN-2020-0461 EUDAMED
IN-2020-1225 EUDAMED
IN-2020-0692 EUDAMED
IN-2020-0394 EUDAMED
IN-2020-0726 EUDAMED
IN-2020-0934 EUDAMED
IN-2020-0947 EUDAMED
INS-8937-R EUDAMED
IN-2020-0697 EUDAMED
IN-2020-0895 EUDAMED
IN-2020-0145 EUDAMED
IN-2020-0540 EUDAMED
IN-2020-0167 EUDAMED
IN-2020-0759 EUDAMED
IN-2020-0485 EUDAMED
IN-2020-0792 EUDAMED
IN-2020-0556 EUDAMED
IN-2020-0925 EUDAMED
IN-2020-0326 EUDAMED
IN-2020-0287 EUDAMED
IN-2020-0580 EUDAMED
IN-2020-0703 EUDAMED
IN-2020-0157 EUDAMED
IN-2020-0888 EUDAMED
IN-2020-0160 EUDAMED
IN-2020-0585 EUDAMED
IN-2020-0883 EUDAMED
IN-2020-0354 EUDAMED
IN-2020-0234 EUDAMED
IN-2020-0408 EUDAMED
IN-2020-0828 EUDAMED
IN-2020-0548 EUDAMED
IN-2020-0674 EUDAMED
IN-2020-0982 EUDAMED
IN-2020-0219 EUDAMED
IN-2020-0710 EUDAMED
IN-2020-0150 EUDAMED
IN-2020-0891 EUDAMED
IN-2020-1214 EUDAMED
IN-2020-0332 EUDAMED
IN-2020-0886 EUDAMED
IN-2020-0171 EUDAMED
IN-2020-0696 EUDAMED
IN-2020-0464 EUDAMED
IN-2020-1045 EUDAMED
IN-2020-0435 EUDAMED
IN-2020-0204 EUDAMED
IN-2020-0353 EUDAMED
IN-2020-1290 EUDAMED
IN-2020-1119 EUDAMED
IN-2020-0878 EUDAMED
IN-2020-0522 EUDAMED
IN-2020-0493 EUDAMED
OM-1000-MU (ST-D1) FDA UDI
INS-8936-R FDA UDI

Identifiers

Catalog Number
999-199 FDA UDI
Primary DI / UDI-DI
00385640011112 EUDAMED
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00385640029131 EUDAMEDFDA UDI
00385640015202 EUDAMED
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00385640071086 EUDAMEDFDA UDI
00385640084925 EUDAMEDFDA UDI
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00385640012102 EUDAMED
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00385640011792 EUDAMED
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00385640016377 EUDAMED
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00385640016674 EUDAMED
00385640018821 EUDAMED
00385640027748 EUDAMED
00385640014557 EUDAMED
00385640015196 EUDAMED
00385640050739 EUDAMED
00385640073523 EUDAMED
00385640004473 EUDAMED
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00385640040792 EUDAMED
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00385640012690 EUDAMED
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00385640011709 EUDAMED
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00385640016100 EUDAMED
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00385640035491 EUDAMED
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00385640070843 EUDAMED
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00385640014854 EUDAMED
00385640034296 EUDAMED
00385640039376 EUDAMED
00385640017787 EUDAMED
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00385640003513 EUDAMED
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00385640077675 EUDAMED
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00385640015363 EUDAMED
00385640018968 EUDAMED
00385640031899 EUDAMED
00385640028158 EUDAMED
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00385640054584 EUDAMED
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00385640037228 EUDAMED
00385640017176 EUDAMED
00385640081597 EUDAMED
00385640035460 EUDAMED
00385640076616 EUDAMED
00385640064477 EUDAMED
00385640040891 EUDAMED
00385640046855 EUDAMED
00385640077941 EUDAMED
00385640015295 EUDAMED
00385640031998 EUDAMED
00385640018258 EUDAMED
00385640074810 EUDAMED
00385640005371 EUDAMED
00385640013871 EUDAMED
00385640054256 EUDAMED
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00385640069595 EUDAMED
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00385640017183 EUDAMED
00385640054263 EUDAMED
00385640054041 EUDAMED
00385640082099 EUDAMED
00385640010702 EUDAMED
00385640029735 EUDAMED
00385640044493 EUDAMED
00385640077934 EUDAMED
00385640017008 EUDAMED
00385640074230 EUDAMED
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00385640013154 EUDAMED
00385640005203 EUDAMED
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00385640083003 EUDAMED
00385640011327 EUDAMED
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00385640012652 EUDAMED
00385640010009 EUDAMED
00385640036399 EUDAMED
00385640017213 EUDAMED
00385640011518 EUDAMED
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00385640019231 EUDAMED
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00385640011808 EUDAMED
00385640009997 EUDAMED
00385640003919 EUDAMED
00385640012843 EUDAMED
00385640047166 EUDAMED
00385640051675 EUDAMED
00385640022187 EUDAMED
00385640020114 EUDAMED
00385640083164 EUDAMED
00385640018548 EUDAMED
00385640036856 EUDAMED
00385640051934 EUDAMED
00385640049962 EUDAMED
00385640062718 EUDAMED
00385640081870 EUDAMED
00385640018951 EUDAMED
00385640063043 EUDAMED
00385640019354 EUDAMED
00385640026345 EUDAMED
00385640002639 EUDAMED
00385640008839 EUDAMED
00385640040976 EUDAMED
00385640047777 EUDAMED
00385640017145 EUDAMED
00385640071574 EUDAMED
00385640080804 EUDAMED
00385640079129 EUDAMED
00385640022231 EUDAMED
00385640037082 EUDAMED
00385640075619 EUDAMED
00385640014328 EUDAMED
00385640023993 EUDAMED
00385640020633 EUDAMED
00385640037204 EUDAMED
00385640014106 EUDAMED
00385640077743 EUDAMED
00385640047456 EUDAMED
00385640022255 EUDAMED
00385640044967 EUDAMED
00385640022200 EUDAMED
00385640069892 EUDAMED
00385640078115 EUDAMED
510(k) Number
K051157 FDA UDI
K133015 FDA UDI
K140289 FDA UDI
K141513 FDA UDI
K142630 FDA UDI
K142768 FDA UDI
K150540 FDA UDI
K151166 FDA UDI
K210836 FDA UDI
FDA Product Code
KCT FDA UDI
EMDN Code
V0402 CLINICAL USE TRAYS AND BOWLS EUDAMED
GMDN Term
Instrument tray, reusable FDA UDI
Device sterilization/disinfection container, reusable FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
880.6850 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDIFDA UDI

Single Use

No

FDA UDIFDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDIFDA UDI

Over-the-Counter

Yes

FDA UDIFDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDIFDA UDI

Serial Number

No

FDA UDIFDA UDI

Expiration Date

No

FDA UDIFDA UDI

Manufacturing Date

Yes

FDA UDIFDA UDI
MRI Safety
MR Conditional FDA UDI

InstruSafe by Summit Medical, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Summit Medical, LLC
EUDAMED SRN
US-MF-000026771
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (1206)

  • EUDAMED 2505684a-eba3-40b2-bba9-a69e60453a38 61 fields · synced Oct 1, 2026
  • EUDAMED 27aee3e0-e4e0-467f-a24f-bdc0d103dd0e 61 fields · synced May 11, 2026
  • EUDAMED 37c1cbbc-d20d-4569-8532-cc30069e3669 61 fields · synced May 11, 2026
  • EUDAMED 3b7724b6-4c69-4aee-b713-625c0e51b723 61 fields · synced May 11, 2026
  • EUDAMED 3c7551c2-df47-49f8-8c58-47f6c9dfed63 61 fields · synced May 11, 2026
  • EUDAMED 43952969-0e24-433d-b229-482ae47be709 61 fields · synced May 11, 2026
  • EUDAMED 65337d06-d538-41c6-8a61-343de6115bb2 61 fields · synced May 11, 2026
  • EUDAMED 6975645d-c40f-4ac7-b7b4-6e04bc266c71 61 fields · synced May 11, 2026
  • EUDAMED 705096d5-8e47-4caf-8b7b-7d793a8b7855 61 fields · synced May 11, 2026
  • EUDAMED a423757c-48f5-4b17-801c-7e340e3302c8 61 fields · synced May 11, 2026
  • EUDAMED b0b6d924-1f3f-49a0-a9b3-f72185e38d80 61 fields · synced May 11, 2026
  • EUDAMED b56bda53-a261-42de-9f7f-b242833557fd 61 fields · synced May 11, 2026
  • EUDAMED dd5a2e38-64ee-49f4-b29c-1bb3cb92e069 61 fields · synced May 11, 2026
  • EUDAMED e75615ff-2100-4093-b894-e83d4c198937 61 fields · synced May 11, 2026
  • EUDAMED e93d63af-0900-4226-bb04-7c9c645c2433 61 fields · synced May 11, 2026
  • EUDAMED f23bda39-253e-4155-aa99-c925107c0c27 61 fields · synced May 11, 2026
  • EUDAMED fa2cbf2e-f0a6-42d5-b76b-fd820c006627 61 fields · synced May 11, 2026
  • EUDAMED f9cd9038-6588-44bc-b608-54da9076971a 61 fields · synced May 11, 2026
  • EUDAMED 07278eed-c256-49b3-b1ae-345402ce46eb 61 fields · synced May 11, 2026
  • EUDAMED 10303247-ba26-47ea-979d-7358cb5bdc45 61 fields · synced May 11, 2026
  • EUDAMED 16ab4dcc-5990-4737-853e-e4920a99b74c 61 fields · synced May 11, 2026
  • EUDAMED 7532e803-d871-4596-9bd0-affaedc459e2 61 fields · synced May 16, 2026
  • EUDAMED ad585834-9669-4ce8-82c9-acc323e5dba3 61 fields · synced May 16, 2026
  • EUDAMED 753efa0e-c9bd-48b6-a8c5-4fcb39a9110c 61 fields · synced May 16, 2026
  • EUDAMED 603f5e1d-5ae5-41f0-8bc4-777f9333408e 61 fields · synced May 16, 2026
  • EUDAMED 07165c08-f792-4caf-8930-f0d37c7d141b 61 fields · synced May 16, 2026
  • EUDAMED efea3ac7-7f8e-4723-a9b9-8fe97f88031a 61 fields · synced May 16, 2026
  • EUDAMED 51de93bc-4277-4385-8846-957457d05646 61 fields · synced May 16, 2026
  • EUDAMED a567e805-ae4e-4cd2-9550-06e00b9ddfd5 61 fields · synced May 16, 2026
  • EUDAMED 95fc4325-8063-47f5-ae68-fff297759d57 61 fields · synced May 16, 2026
  • EUDAMED 23e73f88-d2b2-42bf-96ab-030427f56fca 61 fields · synced May 16, 2026
  • EUDAMED c12713fe-9c83-4c03-99bd-0a7b2a8ace0b 61 fields · synced May 16, 2026
  • EUDAMED ba45c8c3-1ea6-43f5-bbb7-fdf02f62fb66 61 fields · synced May 16, 2026
  • EUDAMED 255c880b-6a4f-4041-9166-91a2f6e24c97 61 fields · synced May 16, 2026
  • EUDAMED 1b792981-b4f4-4e00-bfd1-4bb6f19be720 61 fields · synced May 16, 2026
  • EUDAMED 86884778-15f1-42c2-a394-a4125ef3d095 61 fields · synced May 16, 2026
  • EUDAMED db7f5407-12aa-4aa3-a555-4894358cfd93 61 fields · synced May 16, 2026
  • EUDAMED 921a33af-198b-4408-a400-f569ff0d65d1 61 fields · synced May 16, 2026
  • EUDAMED 43161a31-854e-4482-9b67-7ee8423c985e 61 fields · synced May 16, 2026
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