Identity
- Trade Name
- Flex-Thread FDA UDI
- Generic Name
- Bone approximation clamp FDA UDI
- Device Name
- Bone Reduction Clamp- Large Pointed FDA UDI
- Model / Reference
- 8811-1 FDA UDI
- Description
- Bone Reduction Clamp- Large Pointed FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840118124973 FDA UDI
- FDA Product Code
- HXD FDA UDI
- GMDN Term
- Bone approximation clamp FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
No
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
Yes
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
Category: Bone approximation clamp
Flex-Thread by Flower Orthopedics Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Sklar® — Sklar Corporation · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Symmetry Martin — SYMMETRY SURGICAL INC. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Flower Orthopedics Corporation
Sources (1)
- FDA UDI 6febdbfe-89ad-40b8-8065-4efc8f50062e 34 fields · synced May 31, 2026