Large Locking Plate, Fusion 021560004

GUDID 06942782480530

Double Medical Technology Inc.

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

• Primary Device ID: 06942782480530
• NIH Device Record Key: e587025f-7e5e-4de4-8e96-d73c28708b5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Large Locking Plate, Fusion
• Version Model Number: 021560004
• Catalog Number: 021560004
• 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: 161 Millimeter
• Width: 17.6 Millimeter
• Device Size Text, specify: 0
• Length: 161 Millimeter
• Width: 17.6 Millimeter
• Device Size Text, specify: 0
• Length: 161 Millimeter
• Width: 17.6 Millimeter
• Device Size Text, specify: 0
• Length: 161 Millimeter
• Width: 17.6 Millimeter
• Device Size Text, specify: 0
• Length: 161 Millimeter
• Width: 17.6 Millimeter
• Device Size Text, specify: 0
• Length: 161 Millimeter
• Width: 17.6 Millimeter
• Device Size Text, specify: 0
• Length: 161 Millimeter
• Width: 17.6 Millimeter
• Device Size Text, specify: 0
• Length: 161 Millimeter
• Width: 17.6 Millimeter
• Device Size Text, specify: 0
• Length: 161 Millimeter
• Width: 17.6 Millimeter
• Device Size Text, specify: 0
• Length: 161 Millimeter
• Width: 17.6 Millimeter
• Device Size Text, specify: 0
• Length: 161 Millimeter
• Width: 17.6 Millimeter
• Device Size Text, specify: 0
• Length: 161 Millimeter
• Width: 17.6 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782480530 [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

[06942782480530]

Moist Heat or Steam Sterilization

[06942782480530]

Moist Heat or Steam Sterilization

[06942782480530]

Moist Heat or Steam Sterilization

[06942782480530]

Moist Heat or Steam Sterilization

[06942782480530]

Moist Heat or Steam Sterilization

[06942782480530]

Moist Heat or Steam Sterilization

[06942782480530]

Moist Heat or Steam Sterilization

[06942782480530]

Moist Heat or Steam Sterilization

[06942782480530]

Moist Heat or Steam Sterilization

[06942782480530]

Moist Heat or Steam Sterilization

[06942782480530]

Moist Heat or Steam Sterilization

[06942782480530]

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 [Large Locking Plate, Fusion]

• 06942782480578: 021560012
• 06942782480561: 021560010
• 06942782480554: 021560008
• 06942782480547: 021560006
• 06942782480530: 021560004