| Primary Device ID | 08903993311462 |
| NIH Device Record Key | 54ba7cdd-7ab6-4d78-9bb7-ac7bae9502eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Auxein Brand Vertaux 5.5 mm Pedicle Screw System |
| Version Model Number | SP-336 |
| Company DUNS | 872194615 |
| Company Name | Auxein Medical Private Limited |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +919910643638 |
| info@auxein.com | |
| Phone | +919910643638 |
| info@auxein.com | |
| Phone | +919910643638 |
| info@auxein.com | |
| Phone | +919910643638 |
| info@auxein.com | |
| Phone | +919910643638 |
| info@auxein.com | |
| Phone | +919910643638 |
| info@auxein.com | |
| Phone | +919910643638 |
| info@auxein.com | |
| Phone | +919910643638 |
| info@auxein.com | |
| Phone | +919910643638 |
| info@auxein.com | |
| Phone | +919910643638 |
| info@auxein.com | |
| Phone | +919910643638 |
| info@auxein.com | |
| Phone | +919910643638 |
| info@auxein.com | |
| Phone | +919910643638 |
| info@auxein.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08903993311462 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08903993311462]
Moist Heat or Steam Sterilization
[08903993311462]
Moist Heat or Steam Sterilization
[08903993311462]
Moist Heat or Steam Sterilization
[08903993311462]
Moist Heat or Steam Sterilization
[08903993311462]
Moist Heat or Steam Sterilization
[08903993311462]
Moist Heat or Steam Sterilization
[08903993311462]
Moist Heat or Steam Sterilization
[08903993311462]
Moist Heat or Steam Sterilization
[08903993311462]
Moist Heat or Steam Sterilization
[08903993311462]
Moist Heat or Steam Sterilization
[08903993311462]
Moist Heat or Steam Sterilization
[08903993311462]
Moist Heat or Steam Sterilization
[08903993311462]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-19 |
| Device Publish Date | 2021-07-09 |
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