Identity
- Trade Name
- SENTINEL EUDAMEDFDA UDI
- Generic Name
- Cannulated surgical drill bit, single-use FDA UDI
- Device Name
- Orthopedic, Non-active, Drill Bit, Sterile, Disposable, Sentinel Cannulated EUDAMEDSENTINEL CANNULATED DRILL BIT, 11 X 229 MM (9") FDA UDI
- Model / Reference
- S8511 EUDAMEDFDA UDI
- Description
- SENTINEL CANNULATED DRILL BIT, 11 X 229 MM (9") FDA UDI
Identifiers
- Catalog Number
- S8511 FDA UDI
- Primary DI / UDI-DI
- 10845854036761 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10845854036761 EUDAMED
- FDA Product Code
- GFG FDA UDI
- EMDN Code
- P091303 ORTHOPAEDIC IMPLANT DRILL BITS, SINGLE-USE EUDAMED
- GMDN Term
- Cannulated surgical drill bit, 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
Category: Joint prosthesis implantation kit, single-use
Sentinel by Conmed Corporation — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-10845854036761 | 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 32f0535c-02ea-487c-be27-4c27cb79484f 61 fields · synced Jun 18, 2026
- FDA UDI ac0f9ff3-9f70-44a0-a1ec-d269905679a8 35 fields · synced May 30, 2026