e-Lock Distal Radius Volar Plate, Extra-Articular, (4 Head Holes), 5 Holes - Lef A3-DND-QF-001-WF3

GUDID 08903993200568

The Radius plates are made 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: 08903993200568
• NIH Device Record Key: 33acdce1-ff30-4436-a2d4-3a2889b246fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: e-Lock Distal Radius Volar Plate, Extra-Articular, (4 Head Holes), 5 Holes - Lef
• Version Model Number: TI-M14.05
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08903993200568 [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

[08903993200568]

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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