Identity
- Trade Name
- STERLING XTRASHARP SHAVER GATOR EUDAMEDFDA UDI
- Generic Name
- Arthroscopic shaver system blade, single-use FDA UDI
- Device Name
- Orthopedic, Non-active, Shaver Blade, Stealth DLC EUDAMEDSTERLING XTRASHARP SHAVER GATOR SHAVER BLADE, 4.2 MM FDA UDI
- Model / Reference
- S9263A EUDAMEDFDA UDI
- Description
- STERLING XTRASHARP SHAVER GATOR SHAVER BLADE, 4.2 MM FDA UDI
Identifiers
- Catalog Number
- S9263A FDA UDI
- Primary DI / UDI-DI
- 20845854605612 EUDAMEDFDA UDI
- Basic UDI-DI
- B-20845854605612 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 Shaver Gator 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-20845854605612 | 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 1f2bde0a-a881-41ae-b810-df95969c34b6 61 fields · synced Jun 17, 2026
- FDA UDI 52348271-6b9a-40b6-adee-c847e70cd41c 37 fields · synced May 30, 2026