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FlexiGRAFT®

FDA UDI

Class II (US FDA UDI)

by Lifenet Health

Identity

Trade Name
FlexiGRAFT® FDA UDI
Generic Name
Tendon graft FDA UDI
Device Name
Connect Pre-Sutured Tendon (5x210 MM) FDA UDI
Model / Reference
FCON50210 FDA UDI
Description
Connect Pre-Sutured Tendon (5x210 MM) FDA UDI

Identifiers

Catalog Number
FCON FDA UDI
Primary DI / UDI-DI
00889858612685 FDA UDI
FDA Product Code
GAT FDA UDI
GMDN Term
Tendon graft FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5000 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 210 Millimeter FDA UDI
Outer Diameter — 5.0 Millimeter FDA UDI

Category: Tendon graft

A comprehensive medical device directory, offering detailed information on the FlexiGRAFT Sterile Connect Pre-Sutured Tendon (5x210 MM). This device is used for connecting pre-sutured tendons to any part of the human body.

Similar devices

Also classified as Tendon graft.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lifenet Health

Sources (1)

  • FDA UDI b3eebda3-e24e-4f53-99e6-d2a44d00eb44 36 fields · synced Jun 27, 2026