| Primary Device ID | 00840996177238 |
| NIH Device Record Key | 8c9ac75e-bced-4980-b07b-f2ef3126a05f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Harrier SA |
| Version Model Number | Y070-28361010 |
| Company DUNS | 078293017 |
| Company Name | Choice Spine, LP |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
| Phone | +1(865)246-3333 |
| info@choicespine.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840996177238 [Primary] |
| OVD | Intervertebral fusion device with integrated fixation, lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840996177238]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-28 |
| Device Publish Date | 2019-06-20 |
| 00840996177245 | Harrier SA 26x32x8, 10 Deg |
| 00840996177238 | 28x36x10,10deg Trial |
| 00840996177221 | 28x36x8,10deg Trial |
| 00840996184052 | HARRIER-SA,SCREW,5.5X40 |
| 00840996184045 | HARRIER-SA,SCREW,5.5X35 |
| 00840996184038 | HARRIER-SA,SCREW,5.5X30 |
| 00840996184021 | HARRIER-SA,SCREW,5.5X25 |
| 00840996184014 | HARRIER-SA,SCREW,5.5X20 |
| 00840996184007 | HARRIER-SA,SCREW,5.0x35 |
| 00840996183994 | HARRIER-SA,SCREW,5.0x40 |
| 00840996183987 | HARRIER-SA,SCREW,5.0x30 |
| 00840996183970 | HARRIER-SA,SCREW,5.0x25 |
| 00840996183963 | HARRIER-SA,SCREW,5.0x20 |
| 00840996192965 | HARRIER-SA,TRIAL,START WEDGE IMPACT 6H |
| 00840996192958 | HARRIER-SA,TRIAL,START WEDGE IMPACT 8H |