Identity
- Trade Name
- Dymaxeon FDA UDI
- Generic Name
- Bone tap, reusable FDA UDI
- Device Name
- Tap - 6.5 screw FDA UDI
- Model / Reference
- 05.5 FDA UDI
- Description
- Tap - 6.5 screw FDA UDI
Identifiers
- Catalog Number
- 09.0734 FDA UDI
- Primary DI / UDI-DI
- 00815500023554 FDA UDI
- FDA Product Code
- NKB FDA UDIMNI FDA UDIMNH FDA UDI
- GMDN Term
- Bone tap, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 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
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
No
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
MR Conditional FDA UDI
Category: Bone tap, reusable
Dymaxeon by Back 2 Basic Direct, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Back 2 Basic Direct, Llc
Sources (1)
- FDA UDI 726675b6-f00b-44f7-95a2-1e3c56217768 35 fields · synced Jun 1, 2026