Identity
- Trade Name
- Dark Star Deformity FDA UDI
- Generic Name
- Bone awl, reusable FDA UDI
- Device Name
- Republic Spine Bone Awl FDA UDI
- Model / Reference
- 100251 FDA UDI
- Description
- Republic Spine Bone Awl FDA UDI
Identifiers
- Catalog Number
- DS0022 FDA UDI
- Primary DI / UDI-DI
- B0751002510 FDA UDI
- FDA Product Code
- MNH FDA UDIMNI FDA UDIKWP FDA UDINKB FDA UDI
- GMDN Term
- Bone awl, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3050 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 Unsafe FDA UDI
Category: Bone awl, reusable
Dark Star Deformity by Republic Spine, 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
- Republic Spine, LLC
Sources (1)
- FDA UDI 27f232f9-9f3c-451f-9944-fb4fcb212910 35 fields · synced Jun 8, 2026