| Primary Device ID | 08903993371718 | 
| NIH Device Record Key | e2312695-ab2a-43da-85dc-a33f8f1348ea | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Ga-mma Nail | 
| Version Model Number | TI-600A-6.4-085 | 
| 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 | |
| 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 | 08903993371718 [Primary] | 
| HSB | Rod, Fixation, Intramedullary And Accessories | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[08903993371718]
Moist Heat or Steam Sterilization
[08903993371718]
Moist Heat or Steam Sterilization
[08903993371718]
Moist Heat or Steam Sterilization
[08903993371718]
Moist Heat or Steam Sterilization
[08903993371718]
Moist Heat or Steam Sterilization
[08903993371718]
Moist Heat or Steam Sterilization
[08903993371718]
Moist Heat or Steam Sterilization
[08903993371718]
Moist Heat or Steam Sterilization
[08903993371718]
Moist Heat or Steam Sterilization
[08903993371718]
Moist Heat or Steam Sterilization
[08903993371718]
Moist Heat or Steam Sterilization
[08903993371718]
Moist Heat or Steam Sterilization
[08903993371718]
Moist Heat or Steam Sterilization
[08903993371718]
Moist Heat or Steam Sterilization
[08903993371718]
Moist Heat or Steam Sterilization
[08903993371718]
Moist Heat or Steam Sterilization
[08903993371718]
Moist Heat or Steam Sterilization
[08903993371718]
Moist Heat or Steam Sterilization
[08903993371718]
Moist Heat or Steam Sterilization
[08903993371718]
Moist Heat or Steam Sterilization
[08903993371718]
Moist Heat or Steam Sterilization
[08903993371718]
Moist Heat or Steam Sterilization
[08903993371718]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-11-02 | 
| Device Publish Date | 2020-10-23 | 
| 08903993373866 | Inner Screw For Ga-mma Nail Type-II, Titanium | 
| 08903993373842 | End Cap For Ga-mma Nail Type-II, Length 15mm, Titanium | 
| 08903993373835 | End Cap For Ga-mma Nail Type-II, Length 10mm, Titanium | 
| 08903993373828 | End Cap For Ga-mma Nail Type-II, Length 5mm, Titanium | 
| 08903993373811 | End Cap For Ga-mma Nail Type-II, Length 0mm, Titanium | 
| 08903993371770 | Ø6.4mm Cannulated Anti-Rotation Screw, Length 115mm, Titanium (For Anti-Rotation Ga-mma Nail) | 
| 08903993371749 | Ø6.4mm Cannulated Anti-Rotation Screw, Length 100mm, Titanium (For Anti-Rotation Ga-mma Nail) | 
| 08903993371732 | Ø6.4mm Cannulated Anti-Rotation Screw, Length 95mm, Titanium (For Anti-Rotation Ga-mma Nail) | 
| 08903993371725 | Ø6.4mm Cannulated Anti-Rotation Screw, Length 90mm, Titanium (For Anti-Rotation Ga-mma Nail) | 
| 08903993371718 | Ø6.4mm Cannulated Anti-Rotation Screw, Length 85mm, Titanium (For Anti-Rotation Ga-mma Nail) | 
| 08903993371701 | Ø6.4mm Cannulated Anti-Rotation Screw, Length 80mm, Titanium (For Anti-Rotation Ga-mma Nail) | 
| 08903993371688 | Ø6.4mm Cannulated Anti-Rotation Screw, Length 70mm, Titanium (For Anti-Rotation Ga-mma Nail) | 
| 08903993371671 | Ø6.4mm Cannulated Anti-Rotation Screw, Length 65mm, Titanium (For Anti-Rotation Ga-mma Nail) | 
| 08903993371664 | Ø6.4mm Cannulated Anti-Rotation Screw, Length 60mm, Titanium | 
| 08903993371503 | Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 80mm, Titanium | 
| 08903993371480 | Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 70mm, Titanium | 
| 08903993371435 | Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 56mm, Titanium | 
| 08903993371428 | Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 54mm, Titanium | 
| 08903993371411 | Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 50mm, Titanium | 
| 08903993371404 | Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 48mm, Titanium | 
| 08903993371381 | Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 44mm, Titanium | 
| 08903993371329 | Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 32mm, Titanium | 
| 08903993371312 | Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 30mm, Titanium | 
| 08903993371305 | Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 28mm, Titanium | 
| 08903993367575 | Ø10.5mm Cephalic Screw For Ga-mma Nail, Length 120mm, Titanium | 
| 08903993367568 | Ø10.5mm Cephalic Screw For Ga-mma Nail, Length 115mm, Titanium | 
| 08903993367551 | Ø10.5mm Cephalic Screw For Ga-mma Nail, Length 110mm, Titanium | 
| 08903993367544 | Ø10.5mm Cephalic Screw For Ga-mma Nail, Length 100mm, Titanium | 
| 08903993367537 | Ø10.5mm Cephalic Screw For Ga-mma Nail, Length 95mm, Titanium | 
| 08903993367520 | Ø10.5mm Cephalic Screw For Ga-mma Nail, Length 90mm, Titanium | 
| 08903993367513 | Ø10.5mm Cephalic Screw For Ga-mma Nail, Length 85mm, Titanium | 
| 08903993367506 | Ø10.5mm Cephalic Screw For Ga-mma Nail, Length 80mm, Titanium | 
| 08903993367490 | Ø10.5mm Cephalic Screw For Ga-mma Nail, Length 75mm, Titanium | 
| 08903993367483 | Ø10.5mm Cephalic Screw For Ga-mma Nail, Length 70mm, Titanium | 
| 08903993363614 | Ø6.4mm Cannulated Anti-Rotation Screw, Length 120mm, Titanium (For Anti-Rotation Ga-mma Nail) | 
| 08903993363584 | Ø10.5mm Cephalic Screw For Ga-mma Nail, Length 105mm, Titanium | 
| 08903993363577 | Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 60mm, Titanium | 
| 08903993363560 | Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 58mm, Titanium |