Identity
- Trade Name
- FIX'IN FDA UDI
- Generic Name
- Craniofacial bone screw, non-bioabsorbable FDA UDI
- Device Name
- Self-drilling screw Ø2.0mm L18mm FDA UDI
- Model / Reference
- PV2018 FDA UDI
- Description
- Self-drilling screw Ø2.0mm L18mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701045242178 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Craniofacial bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Craniofacial bone screw, non-bioabsorbable
Fix'in by Biotech Dental — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Craniofacial bone screw, non-bioabsorbable.
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- LEVEL ONE CMF — KLS-Martin L.P. · Class II
- MatrixMANDIBLE — Synthes · Class II
- OsteoMed — Osteomed Corp. · Class II
- LEVEL ONE NEURO, STERILE — KLS-Martin L.P. · Class II
- Leforte System Bone Screw / GBR System Bone Screw — Jeil Medical Corporation · Class II
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
- Biotech Dental
Sources (1)
- FDA UDI e46b41ed-0842-4303-a344-15aab9e90ddb 34 fields · synced Jun 8, 2026