3.5mm Wise-Lock Medial Distal Tibia Plate, 6 Holes - Right A3-DND-QF-001-WF3

GUDID 08903993203668

The plates are designed in right and left configurations, as well as various length configurations. The plates are contoured to provide a close fit with the distal tibia

Auxein Medical Private Limited

Orthopaedic fixation plate kit, non-bioabsorbable, sterile

• Primary Device ID: 08903993203668
• NIH Device Record Key: 23fd8a04-7303-4a63-8601-67aad7cf27f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.5mm Wise-Lock Medial Distal Tibia Plate, 6 Holes - Right
• Version Model Number: TI-746.106R
• 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	08903993203668 [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

[08903993203668]

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

On-Brand Devices [3.5mm Wise-Lock Medial Distal Tibia Plate, 6 Holes - Right ]

• 08903993203668: The plates are designed in right and left configurations, as well as various length configura
• 08903993203552: The plates are designed in right and left configurations, as well as various length configura