Elastic Nail

GUDID 08903993394212

End Cap for Elastic Nail, Size1, Titanium (For Ø3.0-4.0mm)

Auxein Medical Private Limited

Bone nail end-cap, non-sterile

• Primary Device ID: 08903993394212
• NIH Device Record Key: 1da75a86-dd58-4f5c-ade3-d78f1f8c5970
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elastic Nail
• Version Model Number: 412E-1C
• 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

Customer Support Contacts

• Phone: +919910643638
• Email: info@auxein.com
• Phone: +919910643638
• Email: info@auxein.com
• Phone: +919910643638
• Email: info@auxein.com
• Phone: +919910643638
• Email: info@auxein.com
• Phone: +919910643638
• Email: info@auxein.com
• Phone: +919910643638
• Email: info@auxein.com
• Phone: +919910643638
• Email: info@auxein.com
• Phone: +919910643638
• Email: info@auxein.com
• Phone: +919910643638
• Email: info@auxein.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08903993394212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192003

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08903993394212]

Moist Heat or Steam Sterilization

[08903993394212]

Moist Heat or Steam Sterilization

[08903993394212]

Moist Heat or Steam Sterilization

[08903993394212]

Moist Heat or Steam Sterilization

[08903993394212]

Moist Heat or Steam Sterilization

[08903993394212]

Moist Heat or Steam Sterilization

[08903993394212]

Moist Heat or Steam Sterilization

[08903993394212]

Moist Heat or Steam Sterilization

[08903993394212]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-06
• Device Publish Date: 2020-10-29

On-Brand Devices [Elastic Nail]

• 08903993394229: End Cap for Elastic Nail, Size2, Titanium (For Ø1.5-2.5mm)
• 08903993394212: End Cap for Elastic Nail, Size1, Titanium (For Ø3.0-4.0mm)