Identity
- Trade Name
- BioHorizons FDA UDI
- Generic Name
- Bone tap, reusable FDA UDI
- Device Name
- Internal / Single-stage 3.5mm Bone Tap FDA UDI
- Model / Reference
- PT35 FDA UDI
- Description
- Internal / Single-stage 3.5mm Bone Tap FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847236004309 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Bone tap, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 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
BioHorizons by Biohorizons Implant Systems Inc. — 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 |
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Manufacturer
- Manufacturer
- Biohorizons Implant Systems Inc.
Sources (1)
- FDA UDI 845ca037-ab3f-493f-9b94-f50de8be8bc5 34 fields · synced Jun 1, 2026