Distal Radius Locking Plate I, Large, Combi-holes 020641005

GUDID 06942782451851

Double Medical Technology Inc.

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

• Primary Device ID: 06942782451851
• NIH Device Record Key: ad30c4ec-247e-4180-ba48-fb47f3e1a939
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Distal Radius Locking Plate I, Large, Combi-holes
• Version Model Number: 020641005
• Catalog Number: 020641005
• Company DUNS: 529366055
• Company Name: Double Medical Technology Inc.
• 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

Customer Support Contacts

• Phone: +865926087101
• Email: info@double-medical.com
• Phone: +865926087101
• Email: info@double-medical.com

Device Dimensions

• Length: 74.6 Millimeter
• Width: 8 Millimeter
• Device Size Text, specify: 0
• Length: 74.6 Millimeter
• Width: 8 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782451851 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130108

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[06942782451851]

Moist Heat or Steam Sterilization

[06942782451851]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-01

On-Brand Devices [Distal Radius Locking Plate I, Large, Combi-holes]

• 06942782454968: 020642006
• 06942782454951: 020641006
• 06942782451899: 020642005
• 06942782451882: 020642004
• 06942782451875: 020642003
• 06942782451868: 020642002
• 06942782451851: 020641005
• 06942782451844: 020641004
• 06942782451837: 020641003
• 06942782451820: 020641002