Identity
- Trade Name
- STERLING XTRASHARP EUDAMEDFDA UDI
- Generic Name
- Arthroscopic shaver system blade, single-use FDA UDI
- Device Name
- Orthopedic, Non-active, Shaver Blade, Hub Sterling EUDAMEDSTERLING XTRASHARP FULL RADIUS RESECTOR SHAVER BLADE, 3.5 MM FDA UDI
- Model / Reference
- C9248 EUDAMEDFDA UDI
- Description
- STERLING XTRASHARP FULL RADIUS RESECTOR SHAVER BLADE, 3.5 MM FDA UDI
Identifiers
- Catalog Number
- C9248 FDA UDI
- Primary DI / UDI-DI
- 10845854012536 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10845854012536 EUDAMED
- FDA Product Code
- GFA FDA UDI
- EMDN Code
- K030203 ARTHROSCOPY BLADES, SINGLE-USE EUDAMED
- GMDN Term
- Arthroscopic shaver system blade, 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
Sterling Xtrasharp 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-10845854012536 | 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 7bcb29c6-1098-4cbb-bac8-4b9ece06a979 61 fields · synced Jun 18, 2026
- FDA UDI 1946920d-6405-44d1-a9f8-9af08d6aa2d0 36 fields · synced May 27, 2026
- EUDAMED 9bcb7d93-b1a9-4419-aafd-c8c777004902 61 fields · synced Jun 18, 2026