| Primary Device ID | 00889095717204 |
| NIH Device Record Key | a6385f14-808b-4b26-bc72-0161c6aa856b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NAVIGATION INSTRUMENTS |
| Version Model Number | 682.920 |
| Company DUNS | 139105691 |
| Company Name | GLOBUS MEDICAL, 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 | false |
| OTC Over-The-Counter | false |
| Phone | +1(610)930-1800 |
| info@globusmedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889095717204 [Primary] |
| OLO | Orthopedic stereotaxic instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889095717204]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-05 |
| Device Publish Date | 2019-06-27 |
| 00889095174038 | Pedicle Probe, Straight, GI1 |
| 00889095173840 | Pedicle Probe Thoracic, Straight, GI1 |
| 00889095173819 | Pedicle Probe, Straight, GI1 |
| 00889095717235 | Drill Bit for 4.0mm Screw, CT, GI1 |
| 00889095717228 | Drill Bit for 3.5mm Screw, CT, GI1 |
| 00889095717211 | Screwdriver, 2.5mm Hex, Self Retaining, CT, GI1 |
| 00889095717204 | ELLIPSE Polyaxial Screwdriver, CT, GI1 |
| 00889095717198 | 4.0mm Tap, CT, GI1 |
| 00889095717181 | 3.5mm Tap, CT, GI1 |
| 00889095174137 | 9.5mm Cannulated Tap, GI1 |
| 00889095174069 | 10.5mm Cannulated Tap, GI1 |
| 00889095174052 | 4.0mm Tap, GI1 |
| 00889095174045 | 3.5mm Tap, GI1 |
| 00889095173970 | 8.5mm Cannulated Tap, GI1 |
| 00889095173963 | 7.5mm Cannulated Tap, GI1 |
| 00889095173956 | 6.5mm Cannulated Tap, GI1 |
| 00889095173949 | 5.5mm Cannulated Tap, GI1 |
| 00889095173932 | 5.0mm Cannulated Tap, GI1 |
| 00889095173901 | 8.5mm Tap, GI1 |
| 00889095173895 | 7.5mm Tap, GI1 |
| 00889095173888 | 6.5mm Tap, GI1 |
| 00889095173871 | 5.5mm Tap, GI1 |
| 00889095173864 | 5.0mm Tap, GI1 |
| 00889095173857 | 4.5mm Tap, GI1 |