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JRF GraftLink XL

FDA UDI

Class II (US FDA UDI)

by Joint Restoration Foundation Inc

Identity

Trade Name
JRF GraftLink XL FDA UDI
Generic Name
Tendon graft FDA UDI
Model / Reference
1 FDA UDI

Identifiers

Catalog Number
GRX-001 FDA UDI
Primary DI / UDI-DI
00860424000235 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

Yes

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Tendon graft

JRF GraftLink XL by Joint Restoration Foundation Inc — 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
Joint Restoration Foundation Inc

Sources (1)

  • FDA UDI 207ac495-abbe-4d89-9f8a-fd6b14135b5b 34 fields · synced May 31, 2026