Lateral Tibial Head Buttress Locking Plate I, Comb 020442009

GUDID 06942782478537

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: 06942782478537
• NIH Device Record Key: 1d7f95e9-ac07-49f5-922d-29d166e4ec12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lateral Tibial Head Buttress Locking Plate I, Comb
• Version Model Number: 020442009
• Catalog Number: 020442009
• 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: 226.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 226.6 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782478537 [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

[06942782478537]

Moist Heat or Steam Sterilization

[06942782478537]

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, Comb]

• 06942782479381: 020442013
• 06942782479374: 020442012
• 06942782479367: 020442010
• 06942782479350: 020442008
• 06942782479343: 020442006
• 06942782479336: 020442004
• 06942782479329: 020442003
• 06942782479312: 020441013
• 06942782479305: 020441012
• 06942782479299: 020441010
• 06942782479282: 020441008
• 06942782479275: 020441006
• 06942782479268: 020441004
• 06942782479251: 020441003
• 06942782478544: 020442011
• 06942782478537: 020442009
• 06942782478520: 020442007
• 06942782478513: 020442005
• 06942782478506: 020441011
• 06942782478490: 020441009
• 06942782478483: 020441007
• 06942782478476: 020441005