Identity
- Trade Name
- METIS® FDA UDI
- Generic Name
- Orthopaedic osteotome FDA UDI
- Device Name
- The metatarsal osteotome is used to cut the bone after the pre-cutting stage with the cutting guide, for the insertion of the implant. FDA UDI
- Model / Reference
- 139107ND FDA UDI
- Description
- The metatarsal osteotome is used to cut the bone after the pre-cutting stage with the cutting guide, for the insertion of the implant. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780051497 FDA UDI
- FDA Product Code
- HWM FDA UDI
- GMDN Term
- Orthopaedic osteotome FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Metis® by Newdeal Sas — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Newdeal Sas
Sources (1)
- FDA UDI ba256d20-0abb-476e-9b13-0ac4130eb8cc 35 fields · synced Jun 1, 2026