Identity
- Trade Name
- ENDURA CUDA EUDAMEDFDA UDI
- Generic Name
- Arthroscopic shaver system blade, reusable FDA UDI
- Device Name
- Orthopedic, Non-active, Shaver Blade/Bur, Endura EUDAMEDENDURA CUDA SHAVER BLADE, 3.5 MM FDA UDI
- Model / Reference
- C9153 EUDAMEDFDA UDI
- Description
- ENDURA CUDA SHAVER BLADE, 3.5 MM FDA UDI
Identifiers
- Catalog Number
- C9153 FDA UDI
- Primary DI / UDI-DI
- 20845854013073 EUDAMEDFDA UDI
- Basic UDI-DI
- B-20845854013073 EUDAMED
- 510(k) Number
- K943985 FDA UDI
- FDA Product Code
- HRX FDA UDIHWE FDA UDI
- EMDN Code
- L1999 ARTHROSCOPIC SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Arthroscopic shaver system blade, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.1100 FDA UDI878.4820 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3.5 Millimeter FDA UDI
Endura Cuda 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-20845854013073 | 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 (3)
- EUDAMED a336a1e8-27f0-4d91-8194-f88cd38ad9c9 61 fields · synced Jun 18, 2026
- FDA UDI b1cd1b17-49d7-48b3-9020-f6e8e1e50934 38 fields · synced May 30, 2026
- EUDAMED b132fb69-2a44-456a-8c87-d0baa5086d0e 61 fields · synced Jun 18, 2026