Clavicular Hook Locking Plate I 020042011

GUDID 06902139001375

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: 06902139001375
• NIH Device Record Key: fb91a24e-d093-4578-bf09-20d834d7170c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clavicular Hook Locking Plate I
• Version Model Number: 020042011
• Catalog Number: 020042011
• 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

• Device Size Text, specify: 0
• Length: 139.2 Millimeter
• Width: 10 Millimeter
• Device Size Text, specify: 0
• Length: 139.2 Millimeter
• Width: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	06902139001375 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130108

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[06902139001375]

Moist Heat or Steam Sterilization

[06902139001375]

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 [Clavicular Hook Locking Plate I]

• 06942782453558: 020042007
• 06942782453541: 020041007
• 06942782451370: 020042003
• 06942782451363: 020041003
• 06942782451356: 020042012
• 06942782451349: 020041012
• 06942782405267: 020042008
• 06942782405250: 020042006
• 06942782405243: 020042005
• 06942782405236: 020042004
• 06942782405182: 020041008
• 06942782405175: 020041006
• 06942782405168: 020041005
• 06942782405151: 020041004
• 06902139001375: 020042011
• 06902139001368: 020042010
• 06902139001351: 020042009
• 06902139001344: 020041011
• 06902139001337: 020041010
• 06902139001320: 020041009