2.4mm Wise-Lock Distal Radius Volar Plate, Extra-Articular, (4 Head Holes), 3 Ho A3-DND-QF-001-WF3

GUDID 08903993200551

The Radius plates are made of titanium alloy in left & right combination and are designed various length configurations. The plates are contoured to provide a close fit with radius system.

Auxein Medical Private Limited

Orthopaedic fixation plate kit, non-bioabsorbable, sterile

• Primary Device ID: 08903993200551
• NIH Device Record Key: 31b3b3ca-ce6b-4588-a185-9374a7fc9d49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.4mm Wise-Lock Distal Radius Volar Plate, Extra-Articular, (4 Head Holes), 3 Ho
• Version Model Number: TI-M14.03
• Catalog Number: A3-DND-QF-001-WF3
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08903993200551 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141680

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08903993200551]

Moist Heat or Steam Sterilization

[08903993200551]

Moist Heat or Steam Sterilization

[08903993200551]

Moist Heat or Steam Sterilization

[08903993200551]

Moist Heat or Steam Sterilization

[08903993200551]

Moist Heat or Steam Sterilization

[08903993200551]

Moist Heat or Steam Sterilization

[08903993200551]

Moist Heat or Steam Sterilization

[08903993200551]

Moist Heat or Steam Sterilization

[08903993200551]

Moist Heat or Steam Sterilization

[08903993200551]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-18
• Device Publish Date: 2018-10-31

On-Brand Devices [2.4mm Wise-Lock Distal Radius Volar Plate, Extra-Articular, (4 Head Holes), 3 Ho]

• 08903993200599: The Radius plates are made in left & right combination and are designed various length configura
• 08903993200551: The Radius plates are made of titanium alloy in left & right combination and are designed vario