Identity
- Trade Name
- Brasseler USA FDA UDI
- Generic Name
- Orthopaedic bur, single-use FDA UDI
- Device Name
- L35RF 3.5MM ROUND FDA UDI
- Model / Reference
- 5012005M0 FDA UDI
- Description
- L35RF 3.5MM ROUND FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887919557999 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
- Not 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Brasseler USA by Peter Brasseler Holdings, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Peter Brasseler Holdings, LLC
Sources (1)
- FDA UDI 86c0967b-ee4f-44f9-b902-14a642568851 34 fields · synced May 31, 2026