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Soft Tissue Protector Assembly, 1.6mm/6.3mm, Flex-Thread™

FDA UDI

Class II (US FDA UDI)

by Flower Orthopedics Corporation

Identity

Trade Name
Soft Tissue Protector Assembly, 1.6mm/6.3mm, 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
8532-1 FDA UDI
Description
Intramedullary fixation rod and accessories FDA UDI

Identifiers

Primary DI / UDI-DI
00840118117500 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

No

FDA UDI

Single Use

No

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: General internal orthopaedic fixation system implantation kit

Soft Tissue Protector Assembly, 1.6mm/6.3mm, Flex-Thread™ by Flower Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as General internal orthopaedic fixation system implantation kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Flower Orthopedics Corporation

Sources (1)

  • FDA UDI ae5bffe4-8866-4c63-a39a-c404309db326 34 fields · synced Jun 6, 2026