Identity
- Trade Name
- Brophy FDA UDI
- Generic Name
- Orthopaedic bur, single-use FDA UDI
- Model / Reference
- DB501570R-S FDA UDI
Identifiers
- Catalog Number
- DB501570R-S FDA UDI
- Primary DI / UDI-DI
- 14053613288436 FDA UDI
- FDA Product Code
- GFF FDA UDI
- GMDN Term
- Orthopaedic bur, single-use 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: Orthopaedic bur, single-use
Brophy by Gebr. Brasseler GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bur, single-use.
- RAZEK EQUIPAMENTOS — RAZEK EQUIPAMENTOS LTDA · Class I
- RAZEK EQUIPAMENTOS — RAZEK EQUIPAMENTOS LTDA · Class I
- RAZEK EQUIPAMENTOS — RAZEK EQUIPAMENTOS LTDA · Class I
- Midas Rex — Medtronic Powered Surgical Solutions · Class II
- Midas Rex™ — Medtronic Powered Surgical Solutions · Class II
- RAZEK EQUIPAMENTOS — RAZEK EQUIPAMENTOS LTDA · Class I
- RAZEK EQUIPAMENTOS — RAZEK EQUIPAMENTOS LTDA · Class I
- RAZEK EQUIPAMENTOS — RAZEK EQUIPAMENTOS LTDA · 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
- Gebr. Brasseler GmbH & Co. KG
Sources (1)
- FDA UDI 3cb82f3d-db2a-40d3-a5d2-7e58f4fda54b 33 fields · synced May 30, 2026