| Primary Device ID | 00190837069995 |
| NIH Device Record Key | a0ba4a44-0026-453b-91c0-7d9415cbb02a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rogue |
| Version Model Number | 154-466 |
| Catalog Number | 154-466 |
| 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 | false |
| 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 | 00190837069995 [Primary] |
| HWC | Screw, fixation, bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190837069995]
Moist Heat or Steam Sterilization
[00190837069995]
Moist Heat or Steam Sterilization
[00190837069995]
Moist Heat or Steam Sterilization
[00190837069995]
Moist Heat or Steam Sterilization
[00190837069995]
Moist Heat or Steam Sterilization
[00190837069995]
Moist Heat or Steam Sterilization
[00190837069995]
Moist Heat or Steam Sterilization
[00190837069995]
Moist Heat or Steam Sterilization
[00190837069995]
Moist Heat or Steam Sterilization
[00190837069995]
Moist Heat or Steam Sterilization
[00190837069995]
Moist Heat or Steam Sterilization
[00190837069995]
Moist Heat or Steam Sterilization
[00190837069995]
Moist Heat or Steam Sterilization
[00190837069995]
Moist Heat or Steam Sterilization
[00190837069995]
Moist Heat or Steam Sterilization
[00190837069995]
Moist Heat or Steam Sterilization
[00190837069995]
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 |
| 00190837070106 | Rogue Template |
| 00190837070090 | Hammertoe Counter Push |
| 00190837070083 | Hammertoe Handle Turn Knob |
| 00190837070076 | Hammertoe Handle Body |
| 00190837070069 | Hammertoe Handle Turn Knob |
| 00190837070052 | Hammertoe Handle Body |
| 00190837070045 | Hammertoe Handle Turn Knob |
| 00190837070038 | Hammertoe Handle Turn Knob |
| 00190837070021 | Hammertoe Handle Knob |
| 00190837070014 | Hammertoe Turn Knob |
| 00190837070007 | Hammertoe Drive Handle |
| 00190837069995 | Counter Push Caddy |
| 00190837069988 | Small Driver Caddy |
| 00190837069971 | Large Driver Caddy |
| 00190837069964 | Step Drill Caddy |
| 00190837069957 | Implant Caddy |
| 00190837069940 | Hammertoe Caddy |
| 00190837069933 | Hammertoe Counter Push |
| 00190837069926 | Small Hammertoe Driver, 2.0mm Diameter |
| 00190837069919 | Large Hammertoe Driver, 2.9mm Diameter |
| 00190837069902 | Hammertoe Step Drill |
| 00190837069896 | 114-230 |
| 00190837069889 | 114-206 |
| 00190837069872 | Compression Screw Tray |