JRF VersaGraft 3.5 VRG-351

GUDID 00860424000242

JOINT RESTORATION FOUNDATION INC

Tendon graft
Primary Device ID00860424000242
NIH Device Record Key14bb22d1-b5b2-4efb-b87a-72f64a396332
Commercial Distribution StatusIn Commercial Distribution
Brand NameJRF VersaGraft 3.5
Version Model Number1
Catalog NumberVRG-351
Company DUNS791391233
Company NameJOINT RESTORATION FOUNDATION INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Producttrue
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-877-255-6727
Emailjrfinfo@jrfortho.org

Operating and Storage Conditions

Handling Environment TemperatureBetween -80 Degrees Celsius and -40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100860424000242 [Primary]

FDA Product Code

GATSuture, Nonabsorbable, Synthetic, Polyethylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-19
Device Publish Date2018-09-18

Devices Manufactured by JOINT RESTORATION FOUNDATION INC

00860424000273 - SpeedGraft QuadLink Tendon2024-07-23
00860424000280 - PilotGraft BTB Tendon, 9 mm2024-07-23
00860424000297 - PilotGraft BTB Tendon, 11 mm2024-07-23
00860424000266 - SpeedGraft Achilles Tendon2022-09-08
00860424000259 - JRF PilotGraft BTB2021-04-12
00860424000242 - JRF VersaGraft 3.52018-10-19
00860424000242 - JRF VersaGraft 3.52018-10-19
00860424000204 - JRF SpeedGraft2018-09-19
00860424000211 - JRF GraftLink2018-03-29

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