2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate with Lateral Support, 3 Ho A3-DND-QF-001-WF3

GUDID 08903993202777

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 humerus

Auxein Medical Private Limited

Orthopaedic fixation plate kit, non-bioabsorbable, sterile

• Primary Device ID: 08903993202777
• NIH Device Record Key: b1e05c97-262a-4adb-8a09-7ae9735fc292
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate with Lateral Support, 3 Ho
• Version Model Number: TI-743.103L
• 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	08903993202777 [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

[08903993202777]

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 [2.7/3.5mm Wise-Lock Dorsolateral Distal Humerus Plate with Lateral Support, 3 Ho]

• 08903993202920: The plates are designed in right and left configurations, as well as various length configurat
• 08903993202883: The plates are designed in right and left configurations, as well as various length configurat
• 08903993202777: The plates are designed in right and left configurations, as well as various length configurat
• 08903993202739: The plates are designed in right and left configurations, as well as various length configurat