Distal Medial Tibial Locking Plate III 021492004

GUDID 06902139001504

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: 06902139001504
• NIH Device Record Key: ef473eb0-0d37-4c56-b0bd-5fdb85138236
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Distal Medial Tibial Locking Plate III
• Version Model Number: 021492004
• Catalog Number: 021492004
• 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

• Device Size Text, specify: 0
• Length: 119 Millimeter
• Width: 14 Millimeter
• Device Size Text, specify: 0
• Length: 119 Millimeter
• Width: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	06902139001504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130108

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[06902139001504]

Moist Heat or Steam Sterilization

[06902139001504]

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 Medial Tibial Locking Plate III]

• 06942782477660: 021492010
• 06942782477653: 021492009
• 06942782477646: 021492008
• 06942782477639: 021492006
• 06942782477622: 021491010
• 06942782477615: 021491009
• 06942782477608: 021491008
• 06942782477592: 021491006
• 06902139001542: 021492012
• 06902139001535: 021492011
• 06902139001528: 021492007
• 06902139001511: 021492005
• 06902139001504: 021492004
• 06902139001498: 021492003
• 06902139001481: 021491012
• 06902139001474: 021491011
• 06902139001467: 021491007
• 06902139001450: 021491005
• 06902139001443: 021491004
• 06902139001436: 021491003