Identity
- Trade Name
- CONMED EUDAMEDFDA UDI
- Generic Name
- Orthopaedic bur, single-use FDA UDI
- Device Name
- Orthopedic, Non-active, Handpiece Bur EUDAMEDBARREL, BUR, MEDIUM, 4 X 10 MM FDA UDI
- Model / Reference
- 5091-254 EUDAMED00509125400 FDA UDI
- Description
- BARREL, BUR, MEDIUM, 4 X 10 MM FDA UDI
Identifiers
- Catalog Number
- 5091-254 FDA UDI
- Primary DI / UDI-DI
- 10845854008003 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10845854008003 EUDAMED
- FDA Product Code
- GFF FDA UDI
- EMDN Code
- K030204 ARTHROSCOPY BURS, SINGLE-USE EUDAMED
- GMDN Term
- Orthopaedic bur, single-use 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 UDI
Single Use
Yes
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
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 UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 4 Millimeter FDA UDILength — 10 Millimeter FDA UDI
Category: Orthopaedic bur, single-use
Conmed by Conmed Corporation — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
Sources (2)
- FDA UDI ec889f35-aae9-4a45-b675-8cdd111c4ad6 36 fields · synced Jun 8, 2026
- EUDAMED 6611c775-a1a5-41b5-9044-7e1b58084b40 61 fields · synced Jun 8, 2026