| Primary Device ID | 00190837062965 |
| NIH Device Record Key | ad42e453-0a2c-46ad-982d-2820dd347d6b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Simpact Tri-Fin |
| Version Model Number | 152-156 |
| Catalog Number | 152-156 |
| Company DUNS | 183641617 |
| Company Name | Life Spine, 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 | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 00190837062965 [Primary] |
| OUR | Sacroiliac joint fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190837062965]
Moist Heat or Steam Sterilization
[00190837062965]
Moist Heat or Steam Sterilization
[00190837062965]
Moist Heat or Steam Sterilization
[00190837062965]
Moist Heat or Steam Sterilization
[00190837062965]
Moist Heat or Steam Sterilization
[00190837062965]
Moist Heat or Steam Sterilization
[00190837062965]
Moist Heat or Steam Sterilization
[00190837062965]
Moist Heat or Steam Sterilization
[00190837062965]
Moist Heat or Steam Sterilization
[00190837062965]
Moist Heat or Steam Sterilization
[00190837062965]
Moist Heat or Steam Sterilization
[00190837062965]
Moist Heat or Steam Sterilization
[00190837062965]
Moist Heat or Steam Sterilization
[00190837062965]
Moist Heat or Steam Sterilization
[00190837062965]
Moist Heat or Steam Sterilization
[00190837062965]
Moist Heat or Steam Sterilization
[00190837062965]
Moist Heat or Steam Sterilization
[00190837062965]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-15 |
| Device Publish Date | 2019-11-07 |
| 00190837020743 | 152-12-970 |
| 00190837020736 | 152-12-965 |
| 00190837020729 | 152-12-960 |
| 00190837020712 | 152-12-955 |
| 00190837020705 | 152-12-950 |
| 00190837020699 | 152-12-945 |
| 00190837020682 | 152-12-940 |
| 00190837020675 | 152-12-935 |
| 00190837020668 | 152-12-930 |
| 00190837063337 | Anterior Curette #1 Ang 9" Handle |
| 00190837063320 | Mallet 40mm Head 1lb 9oz - 9 1/2 Long |
| 00190837063313 | Initial Dilation Tube w/ Threads |
| 00190837063306 | 14mm Parallel Pin Offset Guide |
| 00190837063290 | Sleeve Drill, Short |
| 00190837063283 | Parallel Pin Offset Guide, Large Screw |
| 00190837063276 | Pin Holder, Long |
| 00190837063269 | 300mm x 2.4mm Steinmann Pin, Trocar-Flat, 17-4 SS |
| 00190837063252 | 530mm x 2.4mm Steinmann Pin, Flat-Flat, 17-4 SS |
| 00190837063245 | 300mm x 2.4 Steinmann Pin, Threaded-Blunt, CoCr |
| 00190837063238 | Pin Caddy, 300mm x 2.4mm, CoCr Pins |
| 00190837063221 | Steinmann Pin, 300mm x 2.4mm Trocar-Blunt, CoCr |
| 00190837063214 | Steinmann Pin, Threaded-Blunt Ends |
| 00190837063207 | #3 Dilation Tube, with handle |
| 00190837063191 | Locking Screw Driver |
| 00190837063184 | Locking Screw Driver |
| 00190837063177 | SImpact Tri-Fin Screw Driver Button |
| 00190837063160 | SImpact Tri-Fin Screw Driver |
| 00190837063153 | Sleeve Drill |
| 00190837063146 | 8.0mm Drill, Cannulated |
| 00190837063139 | Final Dilation Tube |
| 00190837063122 | Parallel Pin Offset Guide, Large Screw |
| 00190837063115 | PARALLEL PIN OFFSET GUIDE, SMALL SCREW |
| 00190837063108 | Triangular Pin Offset Guide, Large Screw |
| 00190837063092 | Final Dilation Tube |
| 00190837063085 | Depth Gage |
| 00190837063078 | 530mm x 2.4mm Steinmann Pin, Trocar-Blunt, 17-4 SS |
| 00190837063061 | 300mm x 2.4mm Steinmann Pin, Blunt-Blunt, 17-4 SS |
| 00190837063054 | 530mm x 2.4mm Steinmann Pin, Blunt-Blunt 17-4 SS |
| 00190837063047 | 530mm x 2.4mm Steinmann Pin, Threaded-Blunt 17-4 SS |
| 00190837063030 | Parallel Pin Offset Guide, Large Screw |
| 00190837063023 | Parallel Pin Offset Guide, Small Screw |
| 00190837063016 | Pin Holder |
| 00190837063009 | Large Mallet |
| 00190837062996 | Steinmann Pin Caddy, Long Blunt Pins |
| 00190837062989 | Steinmann Pin Caddy, Short Blunt Pins |
| 00190837062972 | Steinmann Pin Caddy, Long Trocar Pins |
| 00190837062965 | Steinmann Pin Caddy, Short Trocar Pins |
| 00190837062958 | Implant Remover |
| 00190837062941 | 1/4 Square Screw Driver, T30 Hexalobe |
| 00190837062934 | SI Screw Driver Sleeve |