| Primary Device ID | 00849044092769 |
| NIH Device Record Key | 1aae6ea7-d91f-4502-a72e-a5e12b7a109d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | 688.311 |
| Company DUNS | 139105691 |
| Company Name | GLOBUS MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Length | 44 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00849044092769 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00849044092769]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-11-22 |
| Device Publish Date | 2016-07-16 |
| 00849044092905 | SP-Fix ARC Plate Pincher |
| 00849044092899 | Plate Pincher |
| 00849044092882 | Rod Cutter |
| 00849044092875 | Small Plate Caddy |
| 00849044092868 | AP Inserter Caddy |
| 00849044092851 | AP Inserter, 44-55mm Plate |
| 00849044092844 | AP Inserter, 35-41mm Plate |
| 00849044092837 | Lateral Barrel Inserter, 44-55mm Plate |
| 00849044092820 | Lateral Barrel Inserter, 35-41mm Plate |
| 00849044092813 | Removal Driver |
| 00849044092806 | Hex Key |
| 00849044092790 | Implant Compressor |
| 00849044092783 | Rod Holder |
| 00849044092776 | Barrel Holder |
| 00849044092769 | Plate Holder, 44-55mm |
| 00849044092752 | Plate Holder, 35-41mm |
| 00849044092745 | Distractor |
| 00849044092738 | Rod Trial |
| 00849044092721 | Plate Trial, 55mm |
| 00849044092714 | Plate Trial, 50mm |
| 00849044092707 | Plate Trial, 47mm |
| 00849044092691 | Plate Trial, 44mm |
| 00849044092684 | Plate Trial, 41mm |
| 00849044092677 | Plate Trial, 38mm |
| 00849044092660 | Plate Trial, 35mm |
| 00849044092653 | Plate Trial, 32mm |
| 00849044092646 | Plate Trial, 29mm |
| 00849044092615 | LP-Ti Barrel Trial, 20mm |
| 00849044092608 | LP-Ti Barrel Trial, 18mm |
| 00849044092592 | LP-Ti Barrel Trial, 16mm |
| 00849044092585 | LP-Ti Barrel Trial, 14mm |
| 00849044092578 | LP-Ti Barrel Trial, 12mm |
| 00849044092561 | LP-Ti Barrel Trial, 10mm |
| 00849044092554 | LP-Ti Barrel Trial, 8mm |
| 00849044092530 | Trial, 20mm |
| 00849044092523 | Trial, 18mm |
| 00849044092516 | Trial, 16mm |
| 00849044092509 | Trial, 14mm |
| 00849044092493 | Trial, 12mm |
| 00849044092486 | Trial, 10mm |
| 00849044092479 | Trial, 8mm |
| 00849044092462 | Rasp |
| 00849044092455 | Spinous Process Rake |
| 00849044089158 | Plate Bender |
| 00849044089141 | Cleaning Tool, Straight |
| 00849044089134 | Cleaning Tool, Angled |
| 00849044089127 | Cleaning Tool, Curette |
| 00849044089110 | Simple Plate Holder |
| 00849044089103 | Double Barrel DTS Guide, Variable Angle |
| 00849044089097 | Double Barrel DTS Guide, Pre-Set Angle, Plate Holder |