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SteriBest
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref CP614-DK-3Ref CP471S-DK-5Ref CP471D1-NM-SBRef CP1038D1-P-1S/LRef CP1038D1-P-3S/LRef CP778-DK-3Ref CP614-DK-2Ref CP471S-DK-2Ref CP471D1Ref CP614-SBRef CP471D1-SBRef CP471D1-P-3S/LRef CP1038D2-NM-SBRef CP1038D2-SBRef CP634-SBRef CP614-NM-SBRef CP471SRef CP471D1-P-1S/L
Identity
- Trade Name
- SteriBest EUDAMEDFDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- SteriBest Instrument Tray EUDAMEDINSTRUMENT TRAY ASSEMBLY 2 X 6 X .75 CONSISTS OF LID & SLOTTED BASE W/ 2-5/16" 3 SLOT KNIFE HOLDER, 2 BARS FDA UDIINSTRUMENT TRAY ASSEMBLY 7.5 X 2.5 X .75 CONSISTS OF LID & SLOTTED BASE W/ 2-5/16" 1 SLOT KNIFE HOLDER, 2 BARS FDA UDIINSTRUMENT TRAY ASSEMBLY 10 X 6 X .75 CONSISTS OF LID, SLOTTED SHALLOW BASE FDA UDIINSTRUMENT TRAY ASSEMBLY 10 X 6 X 1.5 CONSISTS OF LID & SLOTTED DEEP BASE W/ 3-3/16" 1 SLOT PHACO HOLDER, 2 BARS FDA UDIINSTRUMENT TRAY ASSEMBLY 7 X 4 X .75 CONSISTS OF LID, SHALLOW BASE, MAT FDA UDIINSTRUMENT TRAY ASSEMBLY 6.5 X 4 X .75 CONSISTS OF LID, SLOTTED BASE, MAT FDA UDIINSTRUMENT TRAY ASSEMBLY 7.5 X 4 X .75 CONSISTS OF LID, SLOTTED DEEP BASE FDA UDIINSTRUMENT TRAY ASSEMBLY 7 X 4 X .75 CONSISTS OF LID & SLOTTED SHALLOW BASE W/ 3-3/4" 2 SLOT KNIFE HOLDER, 2 BARS FDA UDIINSTRUMENT TRAY ASSEMBLY 7 X 4 X 1.5 CONSISTS OF LID, SLOTTED DEEP BASE, MAT FDA UDIINSTRUMENT TRAY ASSEMBLY 6 X 2.5 X .75 CONSISTS OF LID, SLOTTED BASE, MAT FDA UDIINSTRUMENT TRAY ASSEMBLY 7 X 4 X .75 CONSISTS OF LID & SLOTTED DEEP BASE W/ 3-3/16" 1 SLOT PHACO HOLDER, 2 BARS FDA UDIINSTRUMENT TRAY ASSEMBLY 6 X 2.5 X .75 CONSISTS OF LID, SLOTTED BASE FDA UDIINSTRUMENT TRAY ASSEMBLY 7 X 4 X 1.5 CONSISTS OF LID, DEEP BASE, MAT FDA UDIINSTRUMENT TRAY ASSEMBLY 2 X 6 X .75 CONSISTS OF LID & SLOTTED BASE W/ 2-5/16" 2 SLOT KNIFE HOLDER, 2 BARS FDA UDIINSTRUMENT TRAY ASSEMBLY 7 X 4 X .75 CONSISTS OF LID & SLOTTED SHALLOW BASE W/ 3-3/4" 5 SLOT KNIFE HOLDER, 2 BARS FDA UDIINSTRUMENT TRAY ASSEMBLY 7 X 4 X .75 CONSISTS OF LID & SLOTTED DEEP BASE W/ 3-5/8" 3 SLOT PHACO HOLDER, 2 BARS FDA UDIINSTRUMENT TRAY ASSEMBLY 10 X 6 X 1.5 CONSISTS OF LID, SLOTTED DEEP BASE, INSERT TRAY FDA UDIINSTRUMENT TRAY ASSEMBLY 10 X 6 X 1.5 CONSISTS OF LID & SLOTTED DEEP BASE W/ 3-5/8" 3 SLOT PHACO HOLDER, 2 BARS FDA UDIINSTRUMENT TRAY ASSEMBLY 10 X 6 X 1.5 CONSISTS OF LID, SLOTTED DEEP BASE, MAT, INSERT TRAY, INSERT MAT FDA UDI
- Model / Reference
- CP614-DK-3 EUDAMEDFDA UDICP778-DK-3 EUDAMEDFDA UDICP1038D1-P-1S/L EUDAMEDFDA UDICP471S EUDAMEDFDA UDICP634-SB EUDAMEDFDA UDICP471D1-NM-SB EUDAMEDFDA UDICP471S-DK-2 EUDAMEDFDA UDICP471D1-SB EUDAMEDFDA UDICP614-SB EUDAMEDFDA UDICP471D1-P-1S/L EUDAMEDFDA UDICP614-NM-SB EUDAMEDFDA UDICP471D1 EUDAMEDFDA UDICP614-DK-2 EUDAMEDFDA UDICP471S-DK-5 EUDAMEDFDA UDICP471D1-P-3S/L EUDAMEDFDA UDICP1038D2-NM-SB EUDAMEDFDA UDICP1038D1-P-3S/L EUDAMEDFDA UDICP1038D2-SB EUDAMEDFDA UDICP1038S-NM-SB FDA UDI
- Description
- INSTRUMENT TRAY ASSEMBLY 2 X 6 X .75 CONSISTS OF LID & SLOTTED BASE W/ 2-5/16" 3 SLOT KNIFE HOLDER, 2 BARS FDA UDIINSTRUMENT TRAY ASSEMBLY 7.5 X 2.5 X .75 CONSISTS OF LID & SLOTTED BASE W/ 2-5/16" 1 SLOT KNIFE HOLDER, 2 BARS FDA UDIINSTRUMENT TRAY ASSEMBLY 10 X 6 X .75 CONSISTS OF LID, SLOTTED SHALLOW BASE FDA UDIINSTRUMENT TRAY ASSEMBLY 10 X 6 X 1.5 CONSISTS OF LID & SLOTTED DEEP BASE W/ 3-3/16" 1 SLOT PHACO HOLDER, 2 BARS FDA UDIINSTRUMENT TRAY ASSEMBLY 7 X 4 X .75 CONSISTS OF LID, SHALLOW BASE, MAT FDA UDIINSTRUMENT TRAY ASSEMBLY 6.5 X 4 X .75 CONSISTS OF LID, SLOTTED BASE, MAT FDA UDIINSTRUMENT TRAY ASSEMBLY 7.5 X 4 X .75 CONSISTS OF LID, SLOTTED DEEP BASE FDA UDIINSTRUMENT TRAY ASSEMBLY 7 X 4 X .75 CONSISTS OF LID & SLOTTED SHALLOW BASE W/ 3-3/4" 2 SLOT KNIFE HOLDER, 2 BARS FDA UDIINSTRUMENT TRAY ASSEMBLY 7 X 4 X 1.5 CONSISTS OF LID, SLOTTED DEEP BASE, MAT FDA UDIINSTRUMENT TRAY ASSEMBLY 6 X 2.5 X .75 CONSISTS OF LID, SLOTTED BASE, MAT FDA UDIINSTRUMENT TRAY ASSEMBLY 7 X 4 X .75 CONSISTS OF LID & SLOTTED DEEP BASE W/ 3-3/16" 1 SLOT PHACO HOLDER, 2 BARS FDA UDIINSTRUMENT TRAY ASSEMBLY 6 X 2.5 X .75 CONSISTS OF LID, SLOTTED BASE FDA UDIINSTRUMENT TRAY ASSEMBLY 7 X 4 X 1.5 CONSISTS OF LID, DEEP BASE, MAT FDA UDIINSTRUMENT TRAY ASSEMBLY 2 X 6 X .75 CONSISTS OF LID & SLOTTED BASE W/ 2-5/16" 2 SLOT KNIFE HOLDER, 2 BARS FDA UDIINSTRUMENT TRAY ASSEMBLY 7 X 4 X .75 CONSISTS OF LID & SLOTTED SHALLOW BASE W/ 3-3/4" 5 SLOT KNIFE HOLDER, 2 BARS FDA UDIINSTRUMENT TRAY ASSEMBLY 7 X 4 X .75 CONSISTS OF LID & SLOTTED DEEP BASE W/ 3-5/8" 3 SLOT PHACO HOLDER, 2 BARS FDA UDIINSTRUMENT TRAY ASSEMBLY 10 X 6 X 1.5 CONSISTS OF LID, SLOTTED DEEP BASE, INSERT TRAY FDA UDIINSTRUMENT TRAY ASSEMBLY 10 X 6 X 1.5 CONSISTS OF LID & SLOTTED DEEP BASE W/ 3-5/8" 3 SLOT PHACO HOLDER, 2 BARS FDA UDIINSTRUMENT TRAY ASSEMBLY 10 X 6 X 1.5 CONSISTS OF LID, SLOTTED DEEP BASE, MAT, INSERT TRAY, INSERT MAT FDA UDI
Identifiers
- Catalog Number
- CP614-DK-3 FDA UDICP778-DK-3 FDA UDICP1038S-NM-SB FDA UDICP1038D1-P-1S/L FDA UDICP471S FDA UDICP634-SB FDA UDICP471D1-NM-SB FDA UDI00642356001173 FDA UDICP471D1-SB FDA UDICP614-SB FDA UDICP471D1-P-1S/L FDA UDICP614-NM-SB FDA UDICP471D1 FDA UDICP614-DK-2 FDA UDICP471S-DK-5 FDA UDICP471D1-P-3S/L FDA UDICP1038D2-NM-SB FDA UDICP1038D1-P-3S/L FDA UDICP1038D2-SB FDA UDI
- Primary DI / UDI-DI
- 00642356001241 EUDAMEDFDA UDI00642356001302 EUDAMEDFDA UDI00642356001050 EUDAMEDFDA UDI00642356001166 EUDAMEDFDA UDI00642356001272 EUDAMEDFDA UDI00642356001371 EUDAMEDFDA UDI00642356001173 EUDAMEDFDA UDI00642356001159 EUDAMEDFDA UDI00642356001258 EUDAMEDFDA UDI00642356001135 EUDAMEDFDA UDI00642356001395 EUDAMEDFDA UDI00642356001128 EUDAMEDFDA UDI00642356001234 EUDAMEDFDA UDI00642356001203 EUDAMEDFDA UDI00642356001142 EUDAMEDFDA UDI00642356001364 EUDAMEDFDA UDI00642356001067 EUDAMEDFDA UDI00642356001081 EUDAMEDFDA UDI00642356001104 FDA UDI
- Basic UDI-DI
- 0642356CPTRYJ EUDAMED
- Direct Marketing DI
- 00642356001241 EUDAMED00642356001203 EUDAMED00642356001371 EUDAMED00642356001050 EUDAMED00642356001067 EUDAMED00642356001302 EUDAMED00642356001234 EUDAMED00642356001173 EUDAMED00642356001128 EUDAMED00642356001258 EUDAMED00642356001159 EUDAMED00642356001142 EUDAMED00642356001364 EUDAMED00642356001081 EUDAMED00642356001272 EUDAMED00642356001395 EUDAMED00642356001166 EUDAMED00642356001135 EUDAMED
- FDA Product Code
- LRP FDA UDI
- EMDN Code
- S010401 TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS EUDAMED
- GMDN Term
- Device sterilization/disinfection container, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA 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 UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Device sterilization/disinfection container, reusable
SteriBest by Mastel Surgical Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mastel Surgical Inc.
Sources (37)
- FDA UDI 8f8fdc65-3e9f-4601-93e5-925a89ab1168 35 fields · synced Jul 26, 2026
- FDA UDI 2ec19e31-e77c-4098-9c38-2c17a46c807c 35 fields · synced May 25, 2026
- FDA UDI 1aa4eaed-f071-4407-9ed8-00460124203f 35 fields · synced May 25, 2026
- FDA UDI 3befbe0a-7fcf-41ac-b9fc-0ddcb533bda1 35 fields · synced May 27, 2026
- FDA UDI 3b9b4f65-36f9-4ed6-b225-a4f19506a869 35 fields · synced May 29, 2026
- FDA UDI eceb8e68-063e-435a-adef-906e9e2a0d84 35 fields · synced May 29, 2026
- FDA UDI 8bbd04a4-253b-44c1-a79d-4e0913959e31 35 fields · synced May 29, 2026
- FDA UDI 9e36996b-0b0f-4e23-9c37-35707d52c6fe 35 fields · synced May 30, 2026
- FDA UDI fdb088a3-7ca0-4ca2-bc1a-984f96a38346 35 fields · synced May 30, 2026
- FDA UDI e309faba-9a7b-4996-bc57-47fc5a60ff3b 34 fields · synced May 30, 2026
- FDA UDI b5713b17-de49-4f02-9fe6-04442aee7cfb 35 fields · synced May 30, 2026
- FDA UDI b7f0c15f-6f2e-4957-8f63-bd66b5825702 35 fields · synced May 30, 2026
- FDA UDI 888d7c35-d5c0-4be7-97bf-c8ef7c73572f 35 fields · synced May 30, 2026
- FDA UDI 77c925f9-8165-41e3-b482-ad183f11ef9d 35 fields · synced May 30, 2026
- FDA UDI 3db79af5-238c-45a7-a42f-9b71e992cb8c 35 fields · synced May 30, 2026
- FDA UDI be0907c3-5743-4913-89fa-45eff913db0b 35 fields · synced May 30, 2026
- FDA UDI 10a880df-09f4-4dbd-b766-4dc64765401a 35 fields · synced May 30, 2026
- FDA UDI 6273ed97-484f-4264-991b-0e8ce56dcf97 35 fields · synced May 30, 2026
- FDA UDI 308b85ab-b78d-4038-8166-6cdd0cce3818 35 fields · synced May 30, 2026
- EUDAMED a81d6808-cccc-48ca-a56e-ec66b5c2ceec 61 fields · synced Jul 9, 2026
- EUDAMED 6a6ec671-2f9c-4b55-8302-8aecc1025eea 61 fields · synced Jul 9, 2026
- EUDAMED c56a67f8-163c-47e5-b2d8-50d60b5a1341 61 fields · synced Jul 9, 2026
- EUDAMED a81c5426-3e0a-483b-9e66-4c7be08a8824 61 fields · synced Jul 9, 2026
- EUDAMED 3ce892a6-0b5a-4d0a-bf80-ccbea3a55737 61 fields · synced Jul 10, 2026
- EUDAMED 964a34a3-03d5-451e-9c8d-032f1f47ea58 61 fields · synced Jul 10, 2026
- EUDAMED 03fbf375-64bf-4bca-ba04-0fbe1018e9b5 61 fields · synced Jul 11, 2026
- EUDAMED cc090135-d30b-490d-b2e0-c71a1fc60c26 61 fields · synced Jul 11, 2026
- EUDAMED a04f755a-373c-4f81-9f73-65e7a48050b8 61 fields · synced Jul 13, 2026
- EUDAMED 8eadd260-c4be-49a0-9a64-46db5f3da2df 61 fields · synced Jul 16, 2026
- EUDAMED 31652f99-774a-4990-8b20-eecc1857cf5f 61 fields · synced Jul 16, 2026
- EUDAMED 4b49f512-c1c0-4b30-8fb7-92c65a477b0b 61 fields · synced Jul 16, 2026
- EUDAMED d0111993-e45e-4fa3-a070-85cc3599765d 61 fields · synced Jul 17, 2026
- EUDAMED 4f085d16-a6e8-4c72-9367-84d636682e51 61 fields · synced Jul 17, 2026
- EUDAMED ee51a544-a5e3-462a-a338-6a66dd99b87f 61 fields · synced Jul 17, 2026
- EUDAMED 614d4fae-f828-4841-a691-601dc0ac45af 61 fields · synced Jul 19, 2026
- EUDAMED 23d5cebf-4ee1-4cbc-924b-5896bc56907d 61 fields · synced Jul 24, 2026
- EUDAMED 2314fafc-678b-4c25-96ab-4e28ff2912e4 61 fields · synced Jul 26, 2026