Identity
- Trade Name
- E9000 EUDAMEDFDA UDI
- Generic Name
- Orthopaedic bur, single-use FDA UDI
- Device Name
- Orthopedic, Non-active, Handpiece Bur EUDAMED4 X 48mm E9000 Bur, Round Diamond, 100-120 Grit, Fine FDA UDI
- Model / Reference
- E6240 EUDAMEDFDA UDI
- Description
- 4 X 48mm E9000 Bur, Round Diamond, 100-120 Grit, Fine FDA UDI
Identifiers
- Catalog Number
- E6240 FDA UDI
- Primary DI / UDI-DI
- 10845854011348 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10845854011348 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
E9000 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-10845854011348 | 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 (2)
- EUDAMED 53b99fd2-046f-479e-8d09-9d3cb415d5c4 61 fields · synced May 30, 2026
- FDA UDI d5444184-0d02-45a5-950a-91f34b96f896 35 fields · synced May 30, 2026