Identity
- Trade Name
- MINI-REVO EUDAMEDFDA UDI
- Generic Name
- Cannulated surgical drill bit, reusable FDA UDI
- Device Name
- Orthopedic, Non-active, Reusable Surgical Instrument, Drilling EUDAMEDMINI-REVO DRILL, 1.5 MM FDA UDI
- Model / Reference
- C6115A EUDAMEDFDA UDI
- Description
- MINI-REVO DRILL, 1.5 MM FDA UDI
Identifiers
- Catalog Number
- C6115A FDA UDI
- Primary DI / UDI-DI
- 10845854030752 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10845854030752 EUDAMED
- FDA Product Code
- GFG FDA UDI
- EMDN Code
- L0916 ORTHOPAEDIC SURGERY BURS AND TIPS, REUSABLE EUDAMED
- GMDN Term
- Cannulated surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4820 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
Category: Fluted surgical drill bit, reusable
Mini-Revo by Conmed Corporation — Class I — 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-10845854030752 | 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 cf392a3d-9aad-4c06-b9ab-7ea56068ea05 61 fields · synced Jun 1, 2026
- FDA UDI ccc9ac7f-f83d-4206-a88f-1ddf9b48cc60 36 fields · synced May 30, 2026