Identity
- Trade Name
- De Soutter Medical FDA UDI
- Generic Name
- Metal-cutting bur FDA UDI
- Device Name
- BUR - END & SIDE CUTTING CARBIDE 3.2mm DIA x 66mm FDA UDI
- Model / Reference
- R60-101 FDA UDI
- Description
- BUR - END & SIDE CUTTING CARBIDE 3.2mm DIA x 66mm FDA UDI
Identifiers
- Catalog Number
- R60-101 FDA UDI
- Primary DI / UDI-DI
- 05051471152526 FDA UDI
- FDA Product Code
- GFF FDA UDI
- GMDN Term
- Metal-cutting bur FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Category: Metal-cutting bur
De Soutter Medical by De Soutter Medical, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metal-cutting bur.
- icotec Systems, Deburring tool — Icotec · Class II
- NSK Sterile Burs/Drills — NAKANISHI INC. · Class II
- Preat — PREAT Corporation · Class I
- NSK Sterile Burs/Drills — NAKANISHI INC. · Class II
- Preat — PREAT Corporation · Class I
- VADER Pedicle System, Deburring tool — Icotec · Class II
- NSK Sterile Burs/Drills — NAKANISHI INC. · Class II
- De Soutter Medical — De Soutter Medical, Ltd. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- De Soutter Medical, Ltd.
Sources (1)
- FDA UDI b050b0a6-6ed6-4321-80f6-5385b729199b 34 fields · synced Jun 8, 2026