2.4 mm Variable Angle Volar Rim Distal Radius Plate, 6 Head Holes (Right),3 hole

GUDID 08903993432747

2.4 mm Variable Angle Volar Rim Distal Radius Plate, 6 Head Holes (Right),3 holes

Auxein Medical Private Limited

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

• Primary Device ID: 08903993432747
• NIH Device Record Key: 354c3530-f943-408d-aade-ab109a9b7705
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.4 mm Variable Angle Volar Rim Distal Radius Plate, 6 Head Holes (Right),3 hole
• Version Model Number: Ti-560-06-03R
• 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: +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	08903993432747 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211324

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08903993432747]

Moist Heat or Steam Sterilization

[08903993432747]

Moist Heat or Steam Sterilization

[08903993432747]

Moist Heat or Steam Sterilization

[08903993432747]

Moist Heat or Steam Sterilization

[08903993432747]

Moist Heat or Steam Sterilization

[08903993432747]

Moist Heat or Steam Sterilization

[08903993432747]

Moist Heat or Steam Sterilization

[08903993432747]

Moist Heat or Steam Sterilization

[08903993432747]

Moist Heat or Steam Sterilization

[08903993432747]

Moist Heat or Steam Sterilization

[08903993432747]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-09
• Device Publish Date: 2022-04-30

On-Brand Devices [2.4 mm Variable Angle Volar Rim Distal Radius Plate, 6 Head Holes (Right),3 hole]

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• 08903993537749: 2.4 mm Variable Angle Volar Rim Distal Radius Plate, 6 Head Holes (Right),3 holes
• 08903993432747: 2.4 mm Variable Angle Volar Rim Distal Radius Plate, 6 Head Holes (Right),3 holes
• 08903993432686: 2.4 mm Variable Angle Volar Rim Distal Radius Plate, 6 Head Holes (Right),3 holes