PilotGraft BTB Tendon, 9 mm PSP-091

GUDID 00860424000280

JOINT RESTORATION FOUNDATION INC

Tendon graft
Primary Device ID00860424000280
NIH Device Record Key6cc6dddb-1a22-476f-8aeb-31bf4f91851f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePilotGraft BTB Tendon, 9 mm
Version Model Number1
Catalog NumberPSP-091
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100860424000280 [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 Date2024-07-23
Device Publish Date2024-07-15

Devices Manufactured by JOINT RESTORATION FOUNDATION INC

00860424000273 - SpeedGraft QuadLink Tendon2024-07-23
00860424000280 - PilotGraft BTB Tendon, 9 mm2024-07-23
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
00860424000204 - JRF SpeedGraft2018-09-19
00860424000211 - JRF GraftLink2018-03-29

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