3.5mm Wise-Lock Anterolateral Distal Tibia Plate,11 Holes - Left A3-DND-QF-001-WF3

GUDID 08903993208779

The plates are designed in , Left & Right configration & various length,The plates are contoured to provide a close fit with the Distial Tibia

Auxein Medical Private Limited

Orthopaedic fixation plate kit, non-bioabsorbable, sterile

• Primary Device ID: 08903993208779
• NIH Device Record Key: e501658a-1e1c-47a0-bbf7-5c4e2dd8c432
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.5mm Wise-Lock Anterolateral Distal Tibia Plate,11 Holes - Left
• Version Model Number: WS1.11
• 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: true
• 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

Customer Support Contacts

• Phone: 9910643638
• Email: INFO@AUXEIN.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	08903993208779 [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

[08903993208779]

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: 2018-11-27

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