Identity
- Trade Name
- Milling Drum Extra Extra Coarse FDA UDI
- Generic Name
- Manual bone mill FDA UDI
- Model / Reference
- SMT-SBM-1310-64 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08720828234983 FDA UDI
- FDA Product Code
- LYS FDA UDI
- GMDN Term
- Manual bone mill 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Manual bone mill
Milling Drum Extra Extra Coarse by Spierings Orthopaedics B.V. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual bone mill.
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
- BONE MILL SET — SONTEC INSTRUMENTS, INC. · Class I
- Midas Rex® — Medtronic Powered Surgical Solutions · Class II
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
- BONE MILL — KLS-Martin L.P. · Class I
- BONE GRINDER — SONTEC INSTRUMENTS, INC. · Class I
- Hu-Friedy — HU-FRIEDY MFG CO., LLC · Class I
- SCHWERT — A. Schweickhardt GmbH & Co. KG · 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 |
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Manufacturer
- Manufacturer
- Spierings Orthopaedics B.V.
Sources (1)
- FDA UDI edfe8d5f-6e60-4328-9ea4-f2680f4f0c60 32 fields · synced May 29, 2026