2.4mm Wise-Lock Volar Buttress Plate, left ( 5 Head Holes), Right, 3 holes

GUDID 08903993536988

2.4mm Wise-Lock Volar Buttress Plate, left ( 5 Head Holes), Right, 3 holes

Auxein Medical Private Limited

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

• Primary Device ID: 08903993536988
• NIH Device Record Key: bbd0befd-c29f-4f6c-8a21-3e745fda0103
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.4mm Wise-Lock Volar Buttress Plate, left ( 5 Head Holes), Right, 3 holes
• Version Model Number: Ti-M11.03LS
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08903993536988 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211324

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-03
• Device Publish Date: 2022-04-25

On-Brand Devices [2.4mm Wise-Lock Volar Buttress Plate, left ( 5 Head Holes), Right, 3 holes]

• 08903993536988: 2.4mm Wise-Lock Volar Buttress Plate, left ( 5 Head Holes), Right, 3 holes
• 08903993201060: 2.4mm Wise-Lock Volar Buttress Plate, left ( 5 Head Holes), Right, 3 holes