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

GUDID 08903993537558

2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Wide (Right), 6 head Holes5 holes

Auxein Medical Private Limited

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

• Primary Device ID: 08903993537558
• NIH Device Record Key: 0d34efc0-e0f0-4803-b186-566a49950bd6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Wide (Right), 6 head
• Version Model Number: Ti-546.205RS
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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	08903993537558 [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, Wide (Right), 6 head ]

• 08903993537589: 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Wide (Right), 6 head Holes,8 holes
• 08903993537572: 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Wide (Right), 6 head Holes,7 holes
• 08903993537565: 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Wide (Right), 6 head Holes,6 holes
• 08903993537558: 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Wide (Right), 6 head Holes5 holes
• 08903993537541: 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Wide (Right), 6 head Holes,4 holes
• 08903993537534: 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Wide (Right), 6 head Holes,3 holes
• 08903993537527: 2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Wide (Right), 6 head Holes,2 holes