| Primary Device ID | 08903993538722 | 
| NIH Device Record Key | 445972c0-1b24-4f64-b7e7-7e5999440ad8 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | 2.7mm Cortical Screw, Self-Tapping, (Star Head), 12mm length | 
| Version Model Number | Ti-1242.12S | 
| 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 | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | true | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | +91 9910643638 | 
| info@auxein.com | |
| Phone | +91 9910643638 | 
| info@auxein.com | |
| Phone | +91 9910643638 | 
| info@auxein.com | |
| Phone | +91 9910643638 | 
| info@auxein.com | |
| Phone | +91 9910643638 | 
| info@auxein.com | |
| Phone | +91 9910643638 | 
| info@auxein.com | |
| Phone | +91 9910643638 | 
| info@auxein.com | |
| Phone | +91 9910643638 | 
| info@auxein.com | |
| Phone | +91 9910643638 | 
| info@auxein.com | |
| Phone | +91 9910643638 | 
| info@auxein.com | |
| Phone | +91 9910643638 | 
| info@auxein.com | |
| Phone | +91 9910643638 | 
| info@auxein.com | |
| Phone | +91 9910643638 | 
| info@auxein.com | |
| Phone | +91 9910643638 | 
| info@auxein.com | |
| Phone | +91 9910643638 | 
| info@auxein.com | |
| Phone | +91 9910643638 | 
| info@auxein.com | |
| Phone | +91 9910643638 | 
| info@auxein.com | |
| Phone | +91 9910643638 | 
| info@auxein.com | |
| Phone | +91 9910643638 | 
| info@auxein.com | |
| Phone | +91 9910643638 | 
| info@auxein.com | |
| Phone | +91 9910643638 | 
| info@auxein.com | |
| Phone | +91 9910643638 | 
| info@auxein.com | |
| Phone | +91 9910643638 | 
| info@auxein.com | |
| Phone | +91 9910643638 | 
| info@auxein.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 08903993538722 [Primary] | 
| HRC | Sterilizer, Soft-Lens, Thermal, Battery-Powered | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-05-06 | 
| Device Publish Date | 2022-04-28 | 
| 08903993538722 | 2.7mm Cortical Screw, Self-Tapping, (Star Head), 12mm length | 
| 08903993360354 | 2.7mm Cortical Screw, Self-Tapping, (Star Head), 12mm length |