Ga-mma Nail

GUDID 08903993371527

Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 90mm, Titanium

Auxein Medical Private Limited

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 08903993371527
• NIH Device Record Key: 73a54bd6-ad06-4dbb-b79d-a34b6c5d109b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ga-mma Nail
• Version Model Number: TI-600-090
• 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
• Phone: +919910643638
• Email: info@auxein.com
• Phone: +919910643638
• Email: info@auxein.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08903993371527 [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

[08903993371527]

Moist Heat or Steam Sterilization

[08903993371527]

Moist Heat or Steam Sterilization

[08903993371527]

Moist Heat or Steam Sterilization

[08903993371527]

Moist Heat or Steam Sterilization

[08903993371527]

Moist Heat or Steam Sterilization

[08903993371527]

Moist Heat or Steam Sterilization

[08903993371527]

Moist Heat or Steam Sterilization

[08903993371527]

Moist Heat or Steam Sterilization

[08903993371527]

Moist Heat or Steam Sterilization

[08903993371527]

Moist Heat or Steam Sterilization

[08903993371527]

Moist Heat or Steam Sterilization

[08903993371527]

Moist Heat or Steam Sterilization

[08903993371527]

Moist Heat or Steam Sterilization

[08903993371527]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-02
• Device Publish Date: 2020-10-24

On-Brand Devices [ Ga-mma Nail]

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• 08903993392874: Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 65mm, Titanium
• 08903993371763: Ø6.4mm Cannulated Anti-Rotation Screw, Length 110mm, Titanium (For Anti-Rotation Ga-mma Nail)
• 08903993371756: Ø6.4mm Cannulated Anti-Rotation Screw, Length 105mm, Titanium (For Anti-Rotation Ga-mma Nail)
• 08903993371695: Ø6.4mm Cannulated Anti-Rotation Screw, Length 75mm, Titanium (For Anti-Rotation Ga-mma Nail)
• 08903993371527: Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 90mm, Titanium
• 08903993371510: Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 85mm, Titanium
• 08903993371497: Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 75mm, Titanium
• 08903993371398: Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 46mm, Titanium
• 08903993371374: Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 42mm, Titanium
• 08903993371367: Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 40mm, Titanium
• 08903993371350: Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 38mm, Titanium
• 08903993371343: Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 36mm, Titanium
• 08903993371336: Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 34mm, Titanium
• 08903993367841: Ø4.8mm Locking Bolt, Self Tapping, For Ga-mma Nail, Length 52mm, Titanium