| Primary Device ID | 00889095038699 |
| NIH Device Record Key | 880faaea-afc7-4bed-93ab-efd849b7a8c7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GATEWAY |
| Version Model Number | 129.422 |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Phone | +1(610)930-1800 |
| info@globusmedical.com | |
| Phone | +1(610)930-1800 |
| info@globusmedical.com | |
| Phone | +1(610)930-1800 |
| info@globusmedical.com | |
| Phone | +1(610)930-1800 |
| info@globusmedical.com | |
| Phone | +1(610)930-1800 |
| info@globusmedical.com | |
| Phone | +1(610)930-1800 |
| info@globusmedical.com | |
| Phone | +1(610)930-1800 |
| info@globusmedical.com | |
| Phone | +1(610)930-1800 |
| info@globusmedical.com | |
| Phone | +1(610)930-1800 |
| info@globusmedical.com | |
| Phone | +1(610)930-1800 |
| info@globusmedical.com | |
| Phone | +1(610)930-1800 |
| info@globusmedical.com | |
| Phone | +1(610)930-1800 |
| info@globusmedical.com | |
| Phone | +1(610)930-1800 |
| info@globusmedical.com | |
| Phone | +1(610)930-1800 |
| info@globusmedical.com |
| Length | 22 Millimeter |
| Length | 22 Millimeter |
| Length | 22 Millimeter |
| Length | 22 Millimeter |
| Length | 22 Millimeter |
| Length | 22 Millimeter |
| Length | 22 Millimeter |
| Length | 22 Millimeter |
| Length | 22 Millimeter |
| Length | 22 Millimeter |
| Length | 22 Millimeter |
| Length | 22 Millimeter |
| Length | 22 Millimeter |
| Length | 22 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889095038699 [Primary] |
| KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889095038699]
Moist Heat or Steam Sterilization
[00889095038699]
Moist Heat or Steam Sterilization
[00889095038699]
Moist Heat or Steam Sterilization
[00889095038699]
Moist Heat or Steam Sterilization
[00889095038699]
Moist Heat or Steam Sterilization
[00889095038699]
Moist Heat or Steam Sterilization
[00889095038699]
Moist Heat or Steam Sterilization
[00889095038699]
Moist Heat or Steam Sterilization
[00889095038699]
Moist Heat or Steam Sterilization
[00889095038699]
Moist Heat or Steam Sterilization
[00889095038699]
Moist Heat or Steam Sterilization
[00889095038699]
Moist Heat or Steam Sterilization
[00889095038699]
Moist Heat or Steam Sterilization
[00889095038699]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-10 |
| 00849044036787 | Single Staple, 8.5mm |
| 00849044036770 | Single Staple, 7.5mm |
| 00849044036763 | Single Staple, 6.5mm |
| 00849044036756 | Single Staple, 5.5mm |
| 00849044036749 | Single Staple, 5.0mm |
| 00849044036732 | GATEWAY Thoracolumbar Plate, 100mm |
| 00849044036725 | GATEWAY Thoracolumbar Plate, 96mm |
| 00849044036718 | GATEWAY Thoracolumbar Plate, 92mm |
| 00849044036701 | GATEWAY Thoracolumbar Plate, 88mm |
| 00849044036695 | GATEWAY Thoracolumbar Plate, 84mm |
| 00849044036688 | GATEWAY Thoracolumbar Plate, 80mm |
| 00849044036671 | GATEWAY Thoracolumbar Plate, 76mm |
| 00849044036664 | GATEWAY Thoracolumbar Plate, 72mm |
| 00849044036657 | GATEWAY Thoracolumbar Plate, 68mm |
| 00849044036640 | GATEWAY Thoracolumbar Plate, 64mm |
| 00849044036633 | GATEWAY Thoracolumbar Plate, 60mm |
| 00849044036626 | GATEWAY Thoracolumbar Plate, 56mm |
| 00849044036619 | GATEWAY Thoracolumbar Plate, 52mm |
| 00849044036602 | GATEWAY Thoracolumbar Plate, 48mm |
| 00849044036596 | GATEWAY Thoracolumbar Plate, 44mm |
| 00849044036589 | GATEWAY Thoracolumbar Plate, 42mm |
| 00849044036572 | GATEWAY Thoracolumbar Plate, 40mm |
| 00849044036565 | GATEWAY Thoracolumbar Plate, 38mm |
| 00849044036558 | GATEWAY Thoracolumbar Plate, 36mm |
| 00889095038767 | 7.5mm Threaded Staple, 3 Prong |
| 00889095038750 | GATEWAY Thoracolumbar Plate, 34mm |
| 00889095038743 | GATEWAY Thoracolumbar Plate, 32mm |
| 00889095038736 | GATEWAY Thoracolumbar Plate, 30mm |
| 00889095038729 | GATEWAY Thoracolumbar Plate, 28mm |
| 00889095038712 | GATEWAY Thoracolumbar Plate, 26mm |
| 00889095038705 | GATEWAY Thoracolumbar Plate, 24mm |
| 00889095038699 | GATEWAY Thoracolumbar Plate, 22mm |
| 00889095038682 | GATEWAY Thoracolumbar Plate, 20mm |
| 00889095277692 | 4.0mm Threaded Staple, 3 Prong |
| 00889095277685 | 4.5mm Threaded Staple, 3 Prong |
| 00889095277678 | 5.0mm Threaded Staple, 3 Prong |
| 00889095277661 | 5.5mm Threaded Staple, 3 Prong |
| 00889095277654 | 6.0mm Threaded Staple, 3 Prong |
| 00889095277647 | 6.5mm Threaded Staple, 3 Prong |
| 00889095277630 | 7.0mm Threaded Staple, 3 Prong |