Identity
- Trade Name
- Dark Star Deformity FDA UDI
- Generic Name
- Orthopaedic rod reducer FDA UDI
- Device Name
- Rod Persuader FDA UDI
- Model / Reference
- 100275 FDA UDI
- Description
- Rod Persuader FDA UDI
Identifiers
- Catalog Number
- DS0013 FDA UDI
- Primary DI / UDI-DI
- B0751002750 FDA UDI
- FDA Product Code
- MNI FDA UDIMNH FDA UDINKB FDA UDIKWP FDA UDI
- GMDN Term
- Orthopaedic rod reducer 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: Orthopaedic rod reducer
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 090c0372-4be7-459a-8729-d263a9808fe0 35 fields · synced May 30, 2026