| Primary Device ID | 00889795107510 |
| NIH Device Record Key | cf535435-13b4-41f9-8391-700a00b366b6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Grappler Interference Screw System |
| Version Model Number | P41-941-5560 |
| Catalog Number | P41-941-5560 |
| Company DUNS | 042961576 |
| Company Name | PARAGON 28, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889795107510 [Primary] |
| MBI | Fastener, fixation, nondegradable, soft tissue |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889795107510]
Moist Heat or Steam Sterilization
[00889795107510]
Moist Heat or Steam Sterilization
[00889795107510]
Moist Heat or Steam Sterilization
[00889795107510]
Moist Heat or Steam Sterilization
[00889795107510]
Moist Heat or Steam Sterilization
[00889795107510]
Moist Heat or Steam Sterilization
[00889795107510]
Moist Heat or Steam Sterilization
[00889795107510]
Moist Heat or Steam Sterilization
[00889795107510]
Moist Heat or Steam Sterilization
[00889795107510]
Moist Heat or Steam Sterilization
[00889795107510]
Moist Heat or Steam Sterilization
[00889795107510]
Moist Heat or Steam Sterilization
[00889795107510]
Moist Heat or Steam Sterilization
[00889795107510]
Moist Heat or Steam Sterilization
[00889795107510]
Moist Heat or Steam Sterilization
[00889795107510]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-22 |
| Device Publish Date | 2022-09-14 |
| 00889795057563 | Suture Passer w/ Braided Nitinol Loop, Grappler™ |
| 00889795057389 | Drill, 8.5 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark |
| 00889795057372 | Drill, 8.0 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark |
| 00889795057365 | Drill, 7.5 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark |
| 00889795057358 | Drill, 7.0 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark |
| 00889795057341 | Drill, 6.5 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark |
| 00889795057334 | Drill, 6.0 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark |
| 00889795057327 | Drill, 5.5 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark |
| 00889795057310 | Drill, 5.0 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark |
| 00889795057303 | Drill, 4.5 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark |
| 00889795057297 | Drill, 4.0 X 130mm, Cannulated, 3/16" Sq. Connection w/ Depth Mark |
| 00889795107589 | PALM Ratcheting Driver Handle w/ AO Connect w/ Suture Cleat |
| 00889795107572 | Blind Tunnel Driver Handle w/ AO Connect w/ Suture Cleat |
| 00889795107565 | Blind-Tunnel Suture Loop Guide Rod w/ Nitinol Loop |
| 00889795107558 | Ø7.0/8.0 Driver Sleeve |
| 00889795107541 | Ø5.5/6.0 Driver Sleeve |
| 00889795107534 | Ø4.5/5.0 Driver Sleeve |
| 00889795107527 | Ø7.0/8.0 Driver, Cannulated |
| 00889795107510 | Ø5.5/6.0 Driver, Cannulated |
| 00889795107503 | Ø8.5 Cannulated Drill w/ Depth Markings |
| 00889795107497 | Ø8.0 Cannulated drill w/ Depth Markings |
| 00889795107206 | Ø7.5 Cannulated Drill w/ Depth Markings |
| 00889795107190 | Ø7.0 Cannulated Drill w/ Depth Markings |
| 00889795107183 | Ø6.5 Cannulated Drill w/ Depth Markings |
| 00889795107176 | Ø6.0 Cannulated Drill w/ Depth Markings |
| 00889795107169 | Ø5.5 Cannulated Drill w/ Depth Markings |
| 00889795107152 | Ø5.0 Cannulated Drill w/ Depth Markings |
| 00889795107145 | Ø4.5 Cannulated Drill w/ Depth Markings |
| 00889795107138 | Ø4.0 Cannulated Drill w/ Depth Markings |
| 00889795106315 | Ø4.5/5.0 Driver, Cannulated |
| 00889795135346 | Ø1.60mm x 20cm Eyelet Kirschner Wire, 316 LVM |