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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
DualLink Presutured Tendon 10.5mm x 210mm FDA UDI
Model / Reference
FDL105210 FDA UDI
Description
DualLink Presutured Tendon 10.5mm x 210mm FDA UDI

Identifiers

Primary DI / UDI-DI
00889858638784 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
Outer Diameter — 10.5 Millimeter FDA UDI
Length — 210 Millimeter FDA UDI

Category: Tendon graft

FlexiGRAFT® by Lifenet Health — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 15cab361-f706-4cbc-8e60-b95d688d1c03 35 fields · synced May 31, 2026