SpeedGraft Achilles Tendon PSA-101

GUDID 00860424000266

JOINT RESTORATION FOUNDATION INC

Tendon graft

• Primary Device ID: 00860424000266
• NIH Device Record Key: a9bde1a8-5011-4dec-a2c4-f75ddc82adc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpeedGraft Achilles Tendon
• Version Model Number: 1
• Catalog Number: PSA-101
• Company DUNS: 791391233
• Company Name: JOINT RESTORATION FOUNDATION INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Handling Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Handling Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Handling Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Handling Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Handling Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Handling Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Handling Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Handling Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Handling Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Handling Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Handling Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Handling Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Handling Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius
• Handling Environment Temperature: Between -80 Degrees Celsius and -40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860424000266 [Primary]

FDA Product Code

• GAT: Suture, Nonabsorbable, Synthetic, Polyethylene

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-08
• Device Publish Date: 2022-08-31

Devices Manufactured by JOINT RESTORATION FOUNDATION INC

• 00860424000273 - SpeedGraft QuadLink Tendon: 2024-07-23
• 00860424000280 - PilotGraft BTB Tendon, 9 mm: 2024-07-23
• 00860424000297 - PilotGraft BTB Tendon, 11 mm: 2024-07-23
• 00860424000266 - SpeedGraft Achilles Tendon: 2022-09-08
• 00860424000266 - SpeedGraft Achilles Tendon: 2022-09-08
• 00860424000259 - JRF PilotGraft BTB: 2021-04-12
• 00860424000242 - JRF VersaGraft 3.5: 2018-10-19
• 00860424000204 - JRF SpeedGraft: 2018-09-19
• 00860424000211 - JRF GraftLink: 2018-03-29