4.5/5.0mm Wise-Lock Distal Femur Plate, 13 Holes - Left A3-DND-QF-001-WF3

GUDID 08903993216378

The plates are designed in left & Right configuration & various length .The plates are contoured to provide a close fit with the distal femur

Auxein Medical Private Limited

Orthopaedic fixation plate kit, non-bioabsorbable, sterile

• Primary Device ID: 08903993216378
• NIH Device Record Key: c5e5305f-4a82-49e6-9265-a34462b2cfd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4.5/5.0mm Wise-Lock Distal Femur Plate, 13 Holes - Left
• Version Model Number: 748.113L
• 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	08903993216378 [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

[08903993216378]

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: 2018-11-30

On-Brand Devices [4.5/5.0mm Wise-Lock Distal Femur Plate, 13 Holes - Left]

• 08903993216460: The plates are designed in left & Right configuration & various length .The plates are contour
• 08903993216378: The plates are designed in left & Right configuration & various length .The plates are contour