Primary Device ID | 00193982568221 |
NIH Device Record Key | f2a5b667-08ea-4d89-9fe0-92c08f648183 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Version Model Number | 6188.8045 |
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 | 00193982568221 [Primary] |
LXH | Orthopedic manual surgical instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00193982568221]
Moist Heat or Steam Sterilization
[00193982568221]
Moist Heat or Steam Sterilization
[00193982568221]
Moist Heat or Steam Sterilization
[00193982568221]
Moist Heat or Steam Sterilization
[00193982568221]
Moist Heat or Steam Sterilization
[00193982568221]
Moist Heat or Steam Sterilization
[00193982568221]
Moist Heat or Steam Sterilization
[00193982568221]
Moist Heat or Steam Sterilization
[00193982568221]
Moist Heat or Steam Sterilization
[00193982568221]
Moist Heat or Steam Sterilization
[00193982568221]
Moist Heat or Steam Sterilization
[00193982568221]
Moist Heat or Steam Sterilization
[00193982568221]
Moist Heat or Steam Sterilization
[00193982568221]
Moist Heat or Steam Sterilization
[00193982568221]
Moist Heat or Steam Sterilization
[00193982568221]
Moist Heat or Steam Sterilization
[00193982568221]
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 |