Expert Tibia Nial

GUDID 08903993392638

Ø4.4mm Locking Bolt, Self Tapping, Length 28mm, Titanium

Auxein Medical Private Limited

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 08903993392638
• NIH Device Record Key: b7ac0754-53c8-412a-a110-8f8ca926f943
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Expert Tibia Nial
• Version Model Number: TI-520-058-28
• 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
• 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	08903993392638 [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

[08903993392638]

Moist Heat or Steam Sterilization

[08903993392638]

Moist Heat or Steam Sterilization

[08903993392638]

Moist Heat or Steam Sterilization

[08903993392638]

Moist Heat or Steam Sterilization

[08903993392638]

Moist Heat or Steam Sterilization

[08903993392638]

Moist Heat or Steam Sterilization

[08903993392638]

Moist Heat or Steam Sterilization

[08903993392638]

Moist Heat or Steam Sterilization

[08903993392638]

Moist Heat or Steam Sterilization

[08903993392638]

Moist Heat or Steam Sterilization

[08903993392638]

Moist Heat or Steam Sterilization

[08903993392638]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-29
• Device Publish Date: 2020-10-21

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