Identity
- Trade Name
- Sklar® FDA UDI
- Generic Name
- Orthopaedic osteotome FDA UDI
- Device Name
- LUCAS CHISEL, 4MM, 16CM FDA UDI
- Model / Reference
- 40-6400 FDA UDI
- Description
- LUCAS CHISEL, 4MM, 16CM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10649111039324 FDA UDI
- FDA Product Code
- FZO FDA UDI
- GMDN Term
- Orthopaedic osteotome FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic osteotome
Sklar® by Sklar Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic osteotome.
- Stratum Ankle — Medartis Inc. · Class I
- Hayden Medical — Hayden Medical Inc · Class I
- ZOLL-DENTAL — Zoll-Dental · Class I
- Bone Tamp — SONTEC INSTRUMENTS, INC. · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sklar Corporation
Sources (1)
- FDA UDI 4bc0213f-6352-42fb-9756-5db3b2a2c974 33 fields · synced May 30, 2026