| Primary Device ID | 00889095998825 | 
| NIH Device Record Key | db445d73-61bf-4cce-b2f4-dc3aa24bd126 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | N/A | 
| Version Model Number | 6183.1033S | 
| 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 | true | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00889095998825 [Primary] | 
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2019-11-27 | 
| Device Publish Date | 2019-11-19 | 
| 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 |