Identity
- Trade Name
- CONMED EUDAMEDFDA UDI
- Generic Name
- ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY TAPS, REUSABLE EUDAMEDBone awl, reusable FDA UDI
- Device Name
- Orthopedic, Non-active, Reusable Surgical Instrument, Punching EUDAMEDMICROFRACTURE AWL, 30° FDA UDI
- Model / Reference
- 8201 EUDAMEDFDA UDI
- Description
- MICROFRACTURE AWL, 30° FDA UDI
Identifiers
- Catalog Number
- 8201 FDA UDI
- Primary DI / UDI-DI
- 10845854038901 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10845854038901 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L098003 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY TAPS, REUSABLE EUDAMED
- GMDN Term
- Bone awl, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Legislation / Framework
- MDD (Directive 93/42/EEC on Medical Devices) EUDAMED
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Angle — 30 degree FDA UDI
Conmed by Conmed Corporation (orthopaedic and traumatological surgery taps, reusable) — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-10845854038901 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 67 fields · synced May 31, 2026
- FDA UDI be350e3d-4bb5-4897-89d2-1d1af157877d 36 fields · synced May 29, 2026