Identity
- Trade Name
- Minuteman FDA UDI
- Generic Name
- Bone file/rasp, manual, single-use FDA UDI
- Device Name
- Single-Use Bone Rasp FDA UDI
- Model / Reference
- 35-0003-000 FDA UDI
- Description
- Single-Use Bone Rasp FDA UDI
Identifiers
- Primary DI / UDI-DI
- M9433500030000 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Bone file/rasp, manual, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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: Bone file/rasp, manual, single-use
Minuteman by Spinal Simplicity, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone file/rasp, manual, single-use.
- 20mm Dilator — SURGENTEC LLC · Class II
- 3/4 inch Cobb — SURGENTEC LLC · Class II
- Neo Medical Cage kit — Neo Medical Inc. · Class I
- 6mm Dilator — SURGENTEC LLC · Class II
- 10mm Dilator — SURGENTEC LLC · Class II
- 17mm Dilator — SURGENTEC LLC · Class II
- GraftRasp Sterilization Tray — SURGENTEC LLC · Class II
- Neo Medical Cage kit — Neo Medical Inc. · 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
- Spinal Simplicity, LLC
Sources (1)
- FDA UDI 843c3b8f-08ae-4795-bd71-0a89b109be21 33 fields · synced Jun 9, 2026