2.4mm Wise-Lock Distal Radius Volar Plate, Extra-articular, ( 4 Head Holes), Rig

GUDID 08903993200650

Auxein Medical Private Limited

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

• Primary Device ID: 08903993200650
• NIH Device Record Key: 2abc0739-f354-4bf2-87ec-0cd15ab1d4d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.4mm Wise-Lock Distal Radius Volar Plate, Extra-articular, ( 4 Head Holes), Rig
• Version Model Number: Ti-M13.03
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08903993200650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211324

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08903993200650]

Moist Heat or Steam Sterilization

[08903993200650]

Moist Heat or Steam Sterilization

[08903993200650]

Moist Heat or Steam Sterilization

[08903993200650]

Moist Heat or Steam Sterilization

[08903993200650]

Moist Heat or Steam Sterilization

[08903993200650]

Moist Heat or Steam Sterilization

[08903993200650]

Moist Heat or Steam Sterilization

[08903993200650]

Moist Heat or Steam Sterilization

[08903993200650]

Moist Heat or Steam Sterilization

[08903993200650]

Moist Heat or Steam Sterilization

[08903993200650]

Moist Heat or Steam Sterilization

[08903993200650]

Moist Heat or Steam Sterilization

[08903993200650]

Moist Heat or Steam Sterilization

[08903993200650]

Moist Heat or Steam Sterilization

[08903993200650]

Moist Heat or Steam Sterilization

[08903993200650]

Moist Heat or Steam Sterilization

[08903993200650]

Moist Heat or Steam Sterilization

[08903993200650]

Moist Heat or Steam Sterilization

[08903993200650]

Moist Heat or Steam Sterilization

[08903993200650]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-09
• Device Publish Date: 2022-04-29

On-Brand Devices [2.4mm Wise-Lock Distal Radius Volar Plate, Extra-articular, ( 4 Head Holes), Rig]

• 08903993536933: 2.4mm Wise-Lock Distal Radius Volar Plate, Extra-articular, ( 4 Head Holes), Right, 5 holes
• 08903993536926: 2.4mm Wise-Lock Distal Radius Volar Plate, Extra-articular, ( 4 Head Holes), Right, 3 holes
• 08903993200667: 2.4mm Wise-Lock Distal Radius Volar Plate, Extra-articular, ( 4 Head Holes), Right, 5 holes
• 08903993200650: Ti-M13.03