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4.5mm Cannulated Intramedullary Canal Template, Flex-Thread™
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- 4.5mm Cannulated Intramedullary Canal Template, Flex-Thread™ FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Intramedullary fixation rod and accessories FDA UDI
- Model / Reference
- 8620-2-S FDA UDI
- Description
- Intramedullary fixation rod and accessories FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840118116473 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit 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
Yes
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
Category: General internal orthopaedic fixation system implantation kit
4.5mm Cannulated Intramedullary Canal Template, Flex-Thread™ by Flower Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID
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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
- Flower Orthopedics Corporation
Sources (1)
- FDA UDI 44345c7f-358b-4a59-aad7-b0e70550adfa 34 fields · synced May 29, 2026