2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 h

GUDID 08903993537510

2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,8 holes

Auxein Medical Private Limited

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

• Primary Device ID: 08903993537510
• NIH Device Record Key: 787a94ad-0bbf-422a-8781-82bf68c53a68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 h
• Version Model Number: Ti-546.208RS
• 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: true
• 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: +91 9910643638
• Email: info@auxein.com
• Phone: +91 9910643638
• Email: info@auxein.com
• Phone: +91 9910643638
• Email: info@auxein.com
• Phone: +91 9910643638
• Email: info@auxein.com
• Phone: +91 9910643638
• Email: info@auxein.com
• Phone: +91 9910643638
• Email: info@auxein.com
• Phone: +91 9910643638
• Email: info@auxein.com
• Phone: +91 9910643638
• Email: info@auxein.com
• Phone: +91 9910643638
• Email: info@auxein.com
• Phone: +91 9910643638
• Email: info@auxein.com
• Phone: +91 9910643638
• Email: info@auxein.com
• Phone: +91 9910643638
• Email: info@auxein.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08903993537510 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211324

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-05
• Device Publish Date: 2022-04-27

On-Brand Devices [2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 h]

• 08903993537510: 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,8 hole
• 08903993537503: 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,7 hole
• 08903993537497: 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,6 hole
• 08903993537480: 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,5 hole
• 08903993537473: 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,4 hole
• 08903993537466: 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,3 hole
• 08903993391143: 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,8 hole
• 08903993391136: 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,7 hole
• 08903993391129: 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,6 hole
• 08903993359068: 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,5 hole
• 08903993359051: 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,4 hole
• 08903993358856: 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,3 hole
• 08903993358849: 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 head Holes,2 hole