Distal Fibular Locking Plate 020201009

GUDID 06942782407957

Double Medical Technology Inc.

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

• Primary Device ID: 06942782407957
• NIH Device Record Key: 2f4e0284-5e7b-4e5b-951c-baafd3808f68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Distal Fibular Locking Plate
• Version Model Number: 020201009
• Catalog Number: 020201009
• 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
• Phone: +865926087101
• Email: info@double-medical.com
• Phone: +865926087101
• Email: info@double-medical.com
• Phone: +865926087101
• Email: info@double-medical.com
• Phone: +865926087101
• Email: info@double-medical.com
• Phone: +865926087101
• Email: info@double-medical.com
• Phone: +865926087101
• Email: info@double-medical.com
• Phone: +865926087101
• Email: info@double-medical.com
• Phone: +865926087101
• Email: info@double-medical.com
• Phone: +865926087101
• Email: info@double-medical.com
• Phone: +865926087101
• Email: info@double-medical.com

Device Dimensions

• Device Size Text, specify: 0
• Length: 150.5 Millimeter
• Width: 10.4 Millimeter
• Device Size Text, specify: 0
• Length: 150.5 Millimeter
• Width: 10.4 Millimeter
• Device Size Text, specify: 0
• Length: 150.5 Millimeter
• Width: 10.4 Millimeter
• Device Size Text, specify: 0
• Length: 150.5 Millimeter
• Width: 10.4 Millimeter
• Device Size Text, specify: 0
• Length: 150.5 Millimeter
• Width: 10.4 Millimeter
• Device Size Text, specify: 0
• Length: 150.5 Millimeter
• Width: 10.4 Millimeter
• Device Size Text, specify: 0
• Length: 150.5 Millimeter
• Width: 10.4 Millimeter
• Device Size Text, specify: 0
• Length: 150.5 Millimeter
• Width: 10.4 Millimeter
• Device Size Text, specify: 0
• Length: 150.5 Millimeter
• Width: 10.4 Millimeter
• Device Size Text, specify: 0
• Length: 150.5 Millimeter
• Width: 10.4 Millimeter
• Device Size Text, specify: 0
• Length: 150.5 Millimeter
• Width: 10.4 Millimeter
• Device Size Text, specify: 0
• Length: 150.5 Millimeter
• Width: 10.4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782407957 [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

[06942782407957]

Moist Heat or Steam Sterilization

[06942782407957]

Moist Heat or Steam Sterilization

[06942782407957]

Moist Heat or Steam Sterilization

[06942782407957]

Moist Heat or Steam Sterilization

[06942782407957]

Moist Heat or Steam Sterilization

[06942782407957]

Moist Heat or Steam Sterilization

[06942782407957]

Moist Heat or Steam Sterilization

[06942782407957]

Moist Heat or Steam Sterilization

[06942782407957]

Moist Heat or Steam Sterilization

[06942782407957]

Moist Heat or Steam Sterilization

[06942782407957]

Moist Heat or Steam Sterilization

[06942782407957]

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 Fibular Locking Plate]

• 06942782417888: 020202010
• 06942782417871: 020201010
• 06942782407964: 020202009
• 06942782407957: 020201009
• 06942782405618: 020202002
• 06942782405601: 020201002
• 06942782405021: 020202008
• 06942782405014: 020202007
• 06942782405007: 020202006
• 06942782404994: 020202005
• 06942782404987: 020202004
• 06942782404970: 020202003
• 06942782404963: 020201008
• 06942782404956: 020201007
• 06942782404949: 020201006
• 06942782404932: 020201005
• 06942782404925: 020201004
• 06942782404918: 020201003