| Primary Device ID | 00193982536923 |
| NIH Device Record Key | b2f0799f-e637-494f-b86e-bef5ddacc8ce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Version Model Number | 6188.4465 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00193982536923 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00193982536923]
Moist Heat or Steam Sterilization
[00193982536923]
Moist Heat or Steam Sterilization
[00193982536923]
Moist Heat or Steam Sterilization
[00193982536923]
Moist Heat or Steam Sterilization
[00193982536923]
Moist Heat or Steam Sterilization
[00193982536923]
Moist Heat or Steam Sterilization
[00193982536923]
Moist Heat or Steam Sterilization
[00193982536923]
Moist Heat or Steam Sterilization
[00193982536923]
Moist Heat or Steam Sterilization
[00193982536923]
Moist Heat or Steam Sterilization
[00193982536923]
Moist Heat or Steam Sterilization
[00193982536923]
Moist Heat or Steam Sterilization
[00193982536923]
Moist Heat or Steam Sterilization
[00193982536923]
Moist Heat or Steam Sterilization
[00193982536923]
Moist Heat or Steam Sterilization
[00193982536923]
Moist Heat or Steam Sterilization
[00193982536923]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-06 |
| Device Publish Date | 2024-08-29 |
| 00193982567446 | Multi-Tool with AO Connection |
| 00193982615673 | T20 Driver, Cannulated, SR, 100mm, AO Quick Connect |
| 00193982572952 | 3.9mm Cannulated Drill Bit, 185mm |
| 00193982572945 | 2.7mm Cannulated Drill Bit, 140mm |
| 00193982572938 | 1.6/3.9mm Double Sided Drill Guide |
| 00193982568276 | 0.8mm Guidewire Measuring Device, 100mm |
| 00193982568269 | T30 Driver, Cannulated, SR, 155mm, Hall Quick Connect |
| 00193982568252 | T30 Removal Driver, Solid |
| 00193982568245 | 5.0mm Cannulated Drill Bit, 222mm |
| 00193982568238 | 2.0mm Cannulated Drill Bit, 140mm |
| 00193982568221 | 1.6 & 2.8mm Guidewire Measuring Device, 220mm |
| 00193982568214 | 1.1mm & 1.4mm Guidewire Measuring Device, 150mm |
| 00193982568191 | 2.8mm Cleaning Stylet, 230mm |
| 00193982568184 | 3.4mm Cleaning Brush, 230mm |
| 00193982568160 | T15 Driver, Cannulated, SR, 100mm, AO Quick Connect |
| 00193982568153 | T8 Driver, Cannulated, SR, 100mm, AO Quick Connect |
| 00193982568146 | T6 Driver, Cannulated, SR, 90mm, AO Quick Connect |
| 00193982568122 | T6 Removal Driver, Solid |
| 00193982568108 | 1.6mm Cannulated Drill Bit, 85mm |
| 00193982568085 | 2.8mm Drill-Tip Guidewire, 220mm |
| 00193982568078 | 1.6mm Trocar Guidewire, 220mm |
| 00193982568054 | 1.4mm Trocar Guidewire, 150mm |
| 00193982568047 | 1.1mm Trocar Guidewire, 150mm |
| 00193982568030 | 0.8mm Trocar Guidewire, 100mm |
| 00193982568023 | 0.8/1.6mm Double Sided Drill Guide |
| 00193982568016 | 2.8/5.0mm Double Sided Drill Guide |
| 00193982568009 | 4.5/5.5mm Guidewire Sleeve |
| 00193982567996 | 6.5/7.5mm Guidewire Sleeve |
| 00193982567989 | 4.5/5.5mm Tissue Protector |
| 00193982567972 | 6.5/7.5mm Tissue Protector |
| 00193982536923 | 6.5/7.5mm Cannulated Countersink |
| 00193982536916 | 4.5/5.5mm Cannulated Countersink |
| 00193982536909 | 3.5/4.0mm Cannulated Countersink |
| 00193982536893 | 2.5/3.0mm Cannulated Countersink |
| 00193982536886 | 2.0mm Cannulated Countersink |
| 00193982625146 | 12mm Dilator, XLIF |
| 00193982617424 | Slap Hammer |
| 00193982616465 | Straight Handle, IBF |
| 00193982616458 | T-Handle, IBF |
| 00193982566654 | 9mm Dilator, XLIF |
| 00193982616502 | 4mm Bone Pin, 160mm (x2) |
| 00193982616496 | 4mm Bone Pin, 95mm (x2) |
| 00193982567965 | 5mm & 6mm Tensioning Spoon |
| 00193982567958 | 3mm & 4mm Tensioning Spoon |
| 00193982567941 | 1mm & 2mm Tensioning Spoon |
| 00193982567934 | Surveillance Checkpoint Punch |
| 00193982567927 | Pin Driver Tip |
| 00193982567804 | T-Handle Driver |
| 00193982567798 | Sagittal Saw Handpiece, EFlex |
| 00193982567781 | Sawblade Adapter Driver Tip |