Identity
- Trade Name
- Dark Star Deformity FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Rod Holder Forceps FDA UDI
- Model / Reference
- 100267 FDA UDI
- Description
- Rod Holder Forceps FDA UDI
Identifiers
- Catalog Number
- DS0010 FDA UDI
- Primary DI / UDI-DI
- B0751002670 FDA UDI
- FDA Product Code
- NKB FDA UDIKWP FDA UDIMNI FDA UDIMNH FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit 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
Yes
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: General internal orthopaedic fixation system implantation kit
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 b093ab64-22e0-46ad-87ea-74dcf9cb3927 35 fields · synced Jun 8, 2026