2.4 mm Variable Angle Volar Rim Distal Radius Plate, 7 Head Holes (Left),8 holes

GUDID 08903993432853

2.4 mm Variable Angle Volar Rim Distal Radius Plate, 7 Head Holes (Left),8 holes

Auxein Medical Private Limited

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

• Primary Device ID: 08903993432853
• NIH Device Record Key: 2bc44c43-c0f0-4281-887f-32063d5aa188
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.4 mm Variable Angle Volar Rim Distal Radius Plate, 7 Head Holes (Left),8 holes
• Version Model Number: Ti-560-07-08L
• 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	08903993432853 [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

[08903993432853]

Moist Heat or Steam Sterilization

[08903993432853]

Moist Heat or Steam Sterilization

[08903993432853]

Moist Heat or Steam Sterilization

[08903993432853]

Moist Heat or Steam Sterilization

[08903993432853]

Moist Heat or Steam Sterilization

[08903993432853]

Moist Heat or Steam Sterilization

[08903993432853]

Moist Heat or Steam Sterilization

[08903993432853]

Moist Heat or Steam Sterilization

[08903993432853]

Moist Heat or Steam Sterilization

[08903993432853]

Moist Heat or Steam Sterilization

[08903993432853]

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: 2022-04-30

On-Brand Devices [2.4 mm Variable Angle Volar Rim Distal Radius Plate, 7 Head Holes (Left),8 holes]

• 08903993537978: 2.4 mm Variable Angle Volar Rim Distal Radius Plate, 7 Head Holes (Left),8 holes
• 08903993432853: 2.4 mm Variable Angle Volar Rim Distal Radius Plate, 7 Head Holes (Left),8 holes