Lateral Tibial Head Buttress Locking Plate II 021361010

GUDID 06942782477318

Double Medical Technology Inc.

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

• Primary Device ID: 06942782477318
• NIH Device Record Key: d2db372a-4b88-47f5-8865-b141a34c290a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lateral Tibial Head Buttress Locking Plate II
• Version Model Number: 021361010
• Catalog Number: 021361010
• 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

• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 236.6 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782477318 [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

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

Moist Heat or Steam Sterilization

[06942782477318]

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 II]

• 06942782477349: 021362012
• 06942782477332: 021362010
• 06942782477325: 021361012
• 06942782477318: 021361010
• 06942782477301: 021362014
• 06942782477295: 021361014
• 06942782477257: 021362006
• 06942782477240: 021361008
• 06942782477233: 021361006
• 06942782477226: 021361003
• 06942782476991: 021362008
• 06942782476984: 021362003
• 06942782476977: 021362013
• 06942782476960: 021362011
• 06942782476953: 021362009
• 06942782476946: 021362007
• 06942782476939: 021362005
• 06942782476922: 021362004
• 06942782476915: 021361013
• 06942782476908: 021361011
• 06942782476892: 021361009
• 06942782476885: 021361007
• 06942782476878: 021361005
• 06942782476861: 021361004