| Primary Device ID | 08903993209165 | 
| NIH Device Record Key | 0b4d67b4-efc3-485d-88e4-6d17f12bc014 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | 3.5mm Wise-Lock Anterolateral Distal Tibia Plate, 21 Holes - Right | 
| Version Model Number | TI-WS2.21 | 
| Catalog Number | A3-DND-QF-001-WF3 | 
| 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 | false | 
| OTC Over-The-Counter | false | 
| Phone | 9910643638 | 
| INFO@AUXEIN.COM | |
| Phone | 9910643638 | 
| INFO@AUXEIN.COM | |
| Phone | 9910643638 | 
| INFO@AUXEIN.COM | |
| Phone | 9910643638 | 
| INFO@AUXEIN.COM | |
| Phone | 9910643638 | 
| INFO@AUXEIN.COM | |
| Phone | 9910643638 | 
| INFO@AUXEIN.COM | |
| Phone | 9910643638 | 
| INFO@AUXEIN.COM | |
| Phone | 9910643638 | 
| INFO@AUXEIN.COM | |
| Phone | 9910643638 | 
| INFO@AUXEIN.COM | |
| Phone | 9910643638 | 
| INFO@AUXEIN.COM | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 08903993209165 [Primary] | 
| HRS | Plate, Fixation, Bone | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[08903993209165]
Moist Heat or Steam Sterilization
[08903993209165]
Moist Heat or Steam Sterilization
[08903993209165]
Moist Heat or Steam Sterilization
[08903993209165]
Moist Heat or Steam Sterilization
[08903993209165]
Moist Heat or Steam Sterilization
[08903993209165]
Moist Heat or Steam Sterilization
[08903993209165]
Moist Heat or Steam Sterilization
[08903993209165]
Moist Heat or Steam Sterilization
[08903993209165]
Moist Heat or Steam Sterilization
[08903993209165]
Moist Heat or Steam Sterilization
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2019-04-18 | 
| Device Publish Date | 2018-11-27 | 
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| 08903993215555 - 4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 11 Holes | 2024-12-10 The plates are designed in various length,The plates are contoured to provide a close fit with the Humerus,Femur & Tibia | 
| 08903993215562 - 4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 12 Holes | 2024-12-10 The plates are designed in various length,The plates are contoured to provide a close fit with the Humerus,Femur & Tibia | 
| 08903993215579 - 4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 13 Holes | 2024-12-10 The plates are designed in various length,The plates are contoured to provide a close fit with the Humerus,Femur & Tibia | 
| 08903993215586 - 4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 14 Holes | 2024-12-10 The plates are designed in various length,The plates are contoured to provide a close fit with the Humerus,Femur & Tibia | 
| 08903993215593 - 4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 15 Holes | 2024-12-10 The plates are designed in various length,The plates are contoured to provide a close fit with the Humerus,Femur & Tibia | 
| 08903993215609 - 4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 16 Holes | 2024-12-10 The plates are designed in various length,The plates are contoured to provide a close fit with the Humerus,Femur & Tibia | 
| 08903993215616 - 4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 18 Holes | 2024-12-10 The plates are designed in various length,The plates are contoured to provide a close fit with the Humerus,Femur & Tibia |