| Primary Device ID | 00860424000235 |
| NIH Device Record Key | 207ac495-abbe-4d89-9f8a-fd6b14135b5b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | JRF GraftLink XL |
| Version Model Number | 1 |
| Catalog Number | GRX-001 |
| 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 |
| Storage Environment Temperature | Between -80 Degrees Celsius and -40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860424000235 [Primary] |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-03-30 |
| 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 |
| 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 |