Humeral Nail

GUDID 08903993344255

Intramedullary Cannulated Humeral Nail, Ø 7mm x Length 280mm, Titanium

Auxein Medical Private Limited

Humerus nail, non-sterile Humerus nail, non-sterile Humerus nail, non-sterile Humerus nail, non-sterile Humerus nail, non-sterile Humerus nail, non-sterile Humerus nail, non-sterile Humerus nail, non-sterile Humerus nail, non-sterile Humerus nail, non-sterile Humerus nail, non-sterile Humerus nail, non-sterile Humerus nail, non-sterile Humerus nail, non-sterile

• Primary Device ID: 08903993344255
• NIH Device Record Key: 2794d8ef-9c09-416c-ae58-cad52bc017f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Humeral Nail
• Version Model Number: TI-6082-7.0-280
• 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	08903993344255 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192003

FDA Product Code

• JDS: Nail, Fixation, Bone

Sterilization

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

[08903993344255]

Moist Heat or Steam Sterilization

[08903993344255]

Moist Heat or Steam Sterilization

[08903993344255]

Moist Heat or Steam Sterilization

[08903993344255]

Moist Heat or Steam Sterilization

[08903993344255]

Moist Heat or Steam Sterilization

[08903993344255]

Moist Heat or Steam Sterilization

[08903993344255]

Moist Heat or Steam Sterilization

[08903993344255]

Moist Heat or Steam Sterilization

[08903993344255]

Moist Heat or Steam Sterilization

[08903993344255]

Moist Heat or Steam Sterilization

[08903993344255]

Moist Heat or Steam Sterilization

[08903993344255]

Moist Heat or Steam Sterilization

[08903993344255]

Moist Heat or Steam Sterilization

[08903993344255]

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 [ Humeral Nail]

• 08903993344309: Intramedullary Cannulated Humeral Nail, Ø 8mm x Length 220mm, Titanium
• 08903993344293: Intramedullary Cannulated Humeral Nail, Ø 8mm x Length 200mm, Titanium
• 08903993344255: Intramedullary Cannulated Humeral Nail, Ø 7mm x Length 280mm, Titanium
• 08903993344248: Intramedullary Cannulated Humeral Nail, Ø 7mm x Length 260mm, Titanium
• 08903993344224: Intramedullary Cannulated Humeral Nail, Ø 7mm x Length 220mm, Titanium