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Ultrapower
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 7021-116Ref 7021-134Ref 7021-030Ref 7021-015Ref 7021-119Ref 7021-124Ref 7021-127Ref 7021-027Ref 7021-042Ref 7021-173Ref 7021-074Ref 7021-181Ref 7021-141-50Ref 7021-131Ref 7020-015Ref 7021-196Ref 7021-092Ref 7020-014Ref 7021-145-70Ref 7021-041Ref 7021-095Ref 7021-028Ref 7021-123Ref 7020-011Ref 7021-136Ref 7021-177
Identity
- Trade Name
- ULTRAPOWER EUDAMEDFDA UDI
- Generic Name
- Orthopaedic bur, single-use FDA UDISurgical instrument guard, reusable FDA UDI
- Device Name
- Orthopedic, Non-active, Handpiece Bur EUDAMEDOrthopedic, Non-active, Guard, Ultrapower EUDAMEDULTRAPOWER BUR, WIRE PASS (RED), 1.5 MM FDA UDIULTRAPOWER BUR, ROUND(COPPER), 1.5 MM FDA UDIULTRAPOWER BUR, ROUND(COPPER), 8 MM FDA UDIULTRAPOWER BUR, ROUND(COPPER), 2 MM FDA UDIULTRAPOWER REVISION EXTENSION, MEDIUM FDA UDIULTRAPOWER BUR, ROUND COARSE DIAMOND (COPPER), 3 MM FDA UDIULTRAPOWER BUR, ROUND COARSE DIAMOND (RED), 4 MM FDA UDIULTRAPOWER BUR, OVAL (RED), 4 MM X 8 MM FDA UDIULTRAPOWER BUR, TAPERED (COPPER), 2.2 MM X 23 MM FDA UDIULTRAPOWER BUR, ROUND(RED), 6.5 MM FDA UDIULTRAPOWER BUR, ROUND(RED), 4 MM FDA UDIULTRAPOWER BUR, ROUND(COPPER), 4 MM FDA UDIULTRAPOWER BUR, WIRE PASS (RED), 2 MM FDA UDIULTRAPOWER BUR, ACORN (COPPER), 6 MM FDA UDIULTRAPOWER BUR, DIAMOND WHEEL (RED), 25.4 MM FDA UDIULTRAPOWER BUR, ROUND/CYLINDRICAL (COPPER), 2.2 MM FDA UDIULTRAPOWER BUR GUARD, MEDIUM (COPPER) FDA UDIULTRAPOWER BUR, ROUND(COPPER), 7.5 MM FDA UDIULTRAPOWER BUR, TAPERED (RED) 2.2 MM X 16 MM FDA UDIULTRAPOWER BUR, ROUND COARSE DIAMOND (COPPER), 7 MM FDA UDIULTRAPOWER DEPTH LIMITING DRILL (COPPER), 1.5 MM X 7.0 MM FDA UDIULTRAPOWER DEPTH LIMITING DRILL (COPPER), 1.1 X 5.0 MM FDA UDIULTRAPOWER BUR, OVAL (COPPER), 5.5 MM X 10 MM FDA UDIULTRAPOWER REVISION EXTENSION, SHORT FDA UDIULTRAPOWER BUR, TAPERED FISSURE CROSSCUT (COPPER), 1.5 MM X 4.9 MM FDA UDIULTRAPOWER BUR, ROUND(RED), 5 MM FDA UDI
- Model / Reference
- 7021-116 EUDAMED7021-134 EUDAMED7021-030 EUDAMED7021-015 EUDAMED7021-119 EUDAMED7021-124 EUDAMED7021-127 EUDAMED7021-027 EUDAMED7021-042 EUDAMED7021-173 EUDAMED7021-074 EUDAMED7021-181 EUDAMED7021-141-50 EUDAMED7021-131 EUDAMED7020-015 EUDAMED7021-196 EUDAMED7021-092 EUDAMED7020-014 EUDAMED7021-145-70 EUDAMED7021-041 EUDAMED7021-095 EUDAMED7021-028 EUDAMED7021-123 EUDAMED7020-011 EUDAMED7021-136 EUDAMED7021-177 EUDAMED00702104100 FDA UDI00702112300 FDA UDI00702113400 FDA UDI00702112400 FDA UDI00702001500 FDA UDI00702117300 FDA UDI00702107400 FDA UDI00702109500 FDA UDI00702111600 FDA UDI00702103000 FDA UDI00702102700 FDA UDI00702112700 FDA UDI00702104200 FDA UDI00702118100 FDA UDI00702109200 FDA UDI00702113600 FDA UDI00702001100 FDA UDI00702113100 FDA UDI00702101500 FDA UDI00702117700 FDA UDI00702114570 FDA UDI00702114150 FDA UDI00702119600 FDA UDI00702001400 FDA UDI00702111900 FDA UDI00702102800 FDA UDI
- Description
- ULTRAPOWER BUR, WIRE PASS (RED), 1.5 MM FDA UDIULTRAPOWER BUR, ROUND(COPPER), 1.5 MM FDA UDIULTRAPOWER BUR, ROUND(COPPER), 8 MM FDA UDIULTRAPOWER BUR, ROUND(COPPER), 2 MM FDA UDIULTRAPOWER REVISION EXTENSION, MEDIUM FDA UDIULTRAPOWER BUR, ROUND COARSE DIAMOND (COPPER), 3 MM FDA UDIULTRAPOWER BUR, ROUND COARSE DIAMOND (RED), 4 MM FDA UDIULTRAPOWER BUR, OVAL (RED), 4 MM X 8 MM FDA UDIULTRAPOWER BUR, TAPERED (COPPER), 2.2 MM X 23 MM FDA UDIULTRAPOWER BUR, ROUND(RED), 6.5 MM FDA UDIULTRAPOWER BUR, ROUND(RED), 4 MM FDA UDIULTRAPOWER BUR, ROUND(COPPER), 4 MM FDA UDIULTRAPOWER BUR, WIRE PASS (RED), 2 MM FDA UDIULTRAPOWER BUR, ACORN (COPPER), 6 MM FDA UDIULTRAPOWER BUR, DIAMOND WHEEL (RED), 25.4 MM FDA UDIULTRAPOWER BUR, ROUND/CYLINDRICAL (COPPER), 2.2 MM FDA UDIULTRAPOWER BUR GUARD, MEDIUM (COPPER) FDA UDIULTRAPOWER BUR, ROUND(COPPER), 7.5 MM FDA UDIULTRAPOWER BUR, TAPERED (RED) 2.2 MM X 16 MM FDA UDIULTRAPOWER BUR, ROUND COARSE DIAMOND (COPPER), 7 MM FDA UDIULTRAPOWER DEPTH LIMITING DRILL (COPPER), 1.5 MM X 7.0 MM FDA UDIULTRAPOWER DEPTH LIMITING DRILL (COPPER), 1.1 X 5.0 MM FDA UDIULTRAPOWER BUR, OVAL (COPPER), 5.5 MM X 10 MM FDA UDIULTRAPOWER REVISION EXTENSION, SHORT FDA UDIULTRAPOWER BUR, TAPERED FISSURE CROSSCUT (COPPER), 1.5 MM X 4.9 MM FDA UDIULTRAPOWER BUR, ROUND(RED), 5 MM FDA UDI
Identifiers
- Catalog Number
- 7021-041 FDA UDI7021-123 FDA UDI7021-134 FDA UDI7021-124 FDA UDI7020-015 FDA UDI7021-173 FDA UDI7021-074 FDA UDI7021-095 FDA UDI7021-116 FDA UDI7021-030 FDA UDI7021-027 FDA UDI7021-127 FDA UDI7021-042 FDA UDI7021-181 FDA UDI7021-092 FDA UDI7021-136 FDA UDI7020-011 FDA UDI7021-131 FDA UDI7021-015 FDA UDI7021-177 FDA UDI7021-145-70 FDA UDI7021-141-50 FDA UDI7021-196 FDA UDI7020-014 FDA UDI7021-119 FDA UDI7021-028 FDA UDI
- Primary DI / UDI-DI
- 10845854007396 EUDAMEDFDA UDI10845854001738 EUDAMEDFDA UDI10845854002520 EUDAMEDFDA UDI10845854006481 EUDAMEDFDA UDI10845854005118 EUDAMEDFDA UDI10845854008096 EUDAMEDFDA UDI10845854007433 EUDAMEDFDA UDI10845854006573 EUDAMEDFDA UDI10845854004593 EUDAMEDFDA UDI10845854005514 EUDAMEDFDA UDI10845854004623 EUDAMEDFDA UDI10845854003367 EUDAMEDFDA UDI10845854001745 EUDAMEDFDA UDI10845854005132 EUDAMEDFDA UDI10845854023891 EUDAMEDFDA UDI10845854003343 EUDAMEDFDA UDI10845854004708 EUDAMEDFDA UDI10845854023884 EUDAMEDFDA UDI10845854003435 EUDAMEDFDA UDI10845854004531 EUDAMEDFDA UDI10845854004890 EUDAMEDFDA UDI10845854004241 EUDAMEDFDA UDI10845854007471 EUDAMEDFDA UDI10845854023853 EUDAMEDFDA UDI10845854007761 EUDAMEDFDA UDI10845854005484 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10845854007396 EUDAMEDB-10845854001738 EUDAMEDB-10845854002520 EUDAMEDB-10845854006481 EUDAMEDB-10845854005118 EUDAMEDB-10845854008096 EUDAMEDB-10845854007433 EUDAMEDB-10845854006573 EUDAMEDB-10845854004593 EUDAMEDB-10845854005514 EUDAMEDB-10845854004623 EUDAMEDB-10845854003367 EUDAMEDB-10845854001745 EUDAMEDB-10845854005132 EUDAMEDB-10845854023891 EUDAMEDB-10845854003343 EUDAMEDB-10845854004708 EUDAMEDB-10845854023884 EUDAMEDB-10845854003435 EUDAMEDB-10845854004531 EUDAMEDB-10845854004890 EUDAMEDB-10845854004241 EUDAMEDB-10845854007471 EUDAMEDB-10845854023853 EUDAMEDB-10845854007761 EUDAMEDB-10845854005484 EUDAMED
- FDA Product Code
- GFF FDA UDIGET FDA UDIGFG FDA UDI
- EMDN Code
- K030204 ARTHROSCOPY BURS, SINGLE-USE EUDAMEDL80 SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIES EUDAMEDL090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic bur, single-use FDA UDISurgical instrument guard, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDIEUDAMEDFDA UDI
Single Use
Yes
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
Yes
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
Yes
FDA UDIFDA UDI
Manufacturing Date
No
FDA UDIFDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 1.5 Millimeter FDA UDIOuter Diameter — 8 Millimeter FDA UDIOuter Diameter — 2 Millimeter FDA UDIOuter Diameter — 3 Millimeter FDA UDIOuter Diameter — 4 Millimeter FDA UDILength — 8 Millimeter FDA UDIOuter Diameter — 2.2 Millimeter FDA UDILength — 23 Millimeter FDA UDIOuter Diameter — 6.5 Millimeter FDA UDIOuter Diameter — 6 Millimeter FDA UDIOuter Diameter — 25.4 Millimeter FDA UDIOuter Diameter — 7.5 Millimeter FDA UDILength — 16 Millimeter FDA UDIOuter Diameter — 7 Millimeter FDA UDILength — 7 Millimeter FDA UDIOuter Diameter — 1.1 Millimeter FDA UDILength — 5 Millimeter FDA UDILength — 10 Millimeter FDA UDIOuter Diameter — 5.5 Millimeter FDA UDILength — 4.9 Millimeter FDA UDIOuter Diameter — 5 Millimeter FDA UDI
Ultrapower by Conmed Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10845854007396 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (78)
- EUDAMED 7f1caaca-2e4a-4626-9d0d-401fd04f69d6 61 fields · synced Aug 3, 2026
- EUDAMED 99dcfe33-4819-4eb9-8b52-17cd03042eb2 61 fields · synced May 11, 2026
- EUDAMED 311029d8-3c78-4181-9996-1320f7db94e8 61 fields · synced May 16, 2026
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- FDA UDI 31f8b1bc-09de-4554-bb31-4c0d3bda22af 36 fields · synced May 29, 2026
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- EUDAMED c4b18247-cf83-4681-a601-cc31218789a3 61 fields · synced Jul 8, 2026
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- EUDAMED 29b1a3b7-65c2-4959-9010-1bf46604ae85 61 fields · synced Jul 23, 2026
- EUDAMED 6786ee85-c332-44dc-b7db-4beb8e95022f 61 fields · synced Jul 27, 2026
- EUDAMED 92b90776-edaf-439c-87ac-4d11aa0c823c 61 fields · synced Jul 28, 2026
- EUDAMED 9ba2adab-6770-4323-80fd-787996ac3ffb 61 fields · synced Jul 30, 2026
- EUDAMED a570576d-cf97-4fb4-a1af-bfaabcad2d82 61 fields · synced Jul 31, 2026
- EUDAMED 1154ae3f-e728-48b9-8fa1-dbf8316b876a 61 fields · synced Aug 1, 2026
- EUDAMED f012ee5a-9ed7-4a0f-8ab3-130744d95553 61 fields · synced Aug 3, 2026