Distal Femoral Locking Plate II 021351013

GUDID 06942782476434

Double Medical Technology Inc.

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 06942782476434
• NIH Device Record Key: 646c1a06-8c81-4a9b-a189-23047d7ea0ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Distal Femoral Locking Plate II
• Version Model Number: 021351013
• Catalog Number: 021351013
• 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
• 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
• 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

• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0
• Length: 313.9 Millimeter
• Width: 15.326 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782476434 [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

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

Moist Heat or Steam Sterilization

[06942782476434]

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 Femoral Locking Plate II]

• 06942782476458: 021351015
• 06942782476441: 021351014
• 06942782476434: 021351013
• 06942782476427: 021351012
• 06942782476410: 021351011
• 06942782476403: 021351010
• 06942782476397: 021351009
• 06942782476380: 021351008
• 06942782476373: 021351007
• 06942782476366: 021351006
• 06942782476359: 021351005
• 06942782476342: 021352015
• 06942782476335: 021352014
• 06942782476328: 021352013
• 06942782476311: 021352012
• 06942782476304: 021352011
• 06942782476298: 021352010
• 06942782476281: 021352009
• 06942782476274: 021352008
• 06942782476267: 021352007
• 06942782476250: 021352006
• 06942782476243: 021352005