Lateral Tibial Head Buttress Locking Plate Ⅰ 020271006

GUDID 06942782404703

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: 06942782404703
• NIH Device Record Key: b4676975-71e2-4c0c-bebc-66735b1c7897
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lateral Tibial Head Buttress Locking Plate Ⅰ
• Version Model Number: 020271006
• Catalog Number: 020271006
• 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

• Width: 16 Millimeter
• Length: 156.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 156.6 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782404703 [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

[06942782404703]

Moist Heat or Steam Sterilization

[06942782404703]

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 [Lateral Tibial Head Buttress Locking Plate Ⅰ]

• 06942782450199: 020272004
• 06942782450182: 020272003
• 06942782450175: 020271004
• 06942782407940: 020271003
• 06942782406516: 020272014
• 06942782406493: 020271014
• 06942782405724: 020272013
• 06942782405717: 020272012
• 06942782405700: 020272011
• 06942782405694: 020272010
• 06942782405687: 020272009
• 06942782405670: 020272008
• 06942782405663: 020272007
• 06942782405656: 020272006
• 06942782405649: 020272005
• 06942782404772: 020271013
• 06942782404765: 020271012
• 06942782404758: 020271011
• 06942782404741: 020271010
• 06942782404734: 020271009
• 06942782404727: 020271008
• 06942782404710: 020271007
• 06942782404703: 020271006
• 06942782404697: 020271005