Identity
- Trade Name
- Syntec Femoral Nail System FDA UDI
- Generic Name
- Femur nail, non-sterile FDA UDI
- Device Name
- Syntec Femoral Nail System φ11 x L340mm FDA UDI
- Model / Reference
- S880046R FDA UDI
- Description
- Syntec Femoral Nail System φ11 x L340mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04712782905966 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Femur nail, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Femur nail, non-sterile
Syntec Femoral Nail System by Syntec Scientific Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Femur nail, non-sterile.
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- AOS MODULAR NAIL 13.0mm x 46cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
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
- Syntec Scientific Corp.
Sources (1)
- FDA UDI 5767173c-20fb-4f89-9994-8d97e89a3c2c 33 fields · synced Jun 6, 2026