Identity
- Trade Name
- ASSI FDA UDI
- Generic Name
- Orthopaedic osteotome FDA UDI
- Device Name
- Lambotte Osteotome 2mm Bl. 12.5cm FDA UDI
- Model / Reference
- ASSI.ATK2409402 FDA UDI
- Description
- Lambotte Osteotome 2mm Bl. 12.5cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841645130345 FDA UDI
- FDA Product Code
- HNR FDA UDI
- GMDN Term
- Orthopaedic osteotome FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic osteotome
Assi by Accurate Surgical & Scientific Instruments Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic osteotome.
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- Symmetry Lambotte — SYMMETRY SURGICAL INC. · Class I
- gSource — GSOURCE, LLC. · Class I
- INSTRUMENT — Howmedica Osteonics Corp. · Class I
- ORTHOMED — ORTHO-MED, 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 |
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Manufacturer
- Manufacturer
- Accurate Surgical & Scientific Instruments Corp.
Sources (1)
- FDA UDI 21500c89-3ba7-4d3b-8b8b-cf78b649a55e 33 fields · synced May 30, 2026