Proximal Humeral Locking Plate I 020961005

GUDID 06942782475734

Double Medical Technology Inc.

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 06942782475734
• NIH Device Record Key: 616bcc62-424b-493b-a3b4-4ccd6f72c0c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Proximal Humeral Locking Plate I
• Version Model Number: 020961005
• Catalog Number: 020961005
• 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
• Width: 12 Millimeter
• Length: 42.8 Millimeter
• Device Size Text, specify: 0
• Width: 12 Millimeter
• Length: 42.8 Millimeter
• Device Size Text, specify: 0
• Width: 12 Millimeter
• Length: 42.8 Millimeter
• Device Size Text, specify: 0
• Width: 12 Millimeter
• Length: 42.8 Millimeter
• Device Size Text, specify: 0
• Width: 12 Millimeter
• Length: 42.8 Millimeter
• Device Size Text, specify: 0
• Width: 12 Millimeter
• Length: 42.8 Millimeter
• Device Size Text, specify: 0
• Width: 12 Millimeter
• Length: 42.8 Millimeter
• Device Size Text, specify: 0
• Width: 12 Millimeter
• Length: 42.8 Millimeter
• Device Size Text, specify: 0
• Width: 12 Millimeter
• Length: 42.8 Millimeter
• Device Size Text, specify: 0
• Width: 12 Millimeter
• Length: 42.8 Millimeter
• Device Size Text, specify: 0
• Width: 12 Millimeter
• Length: 42.8 Millimeter
• Device Size Text, specify: 0
• Width: 12 Millimeter
• Length: 42.8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782475734 [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

[06942782475734]

Moist Heat or Steam Sterilization

[06942782475734]

Moist Heat or Steam Sterilization

[06942782475734]

Moist Heat or Steam Sterilization

[06942782475734]

Moist Heat or Steam Sterilization

[06942782475734]

Moist Heat or Steam Sterilization

[06942782475734]

Moist Heat or Steam Sterilization

[06942782475734]

Moist Heat or Steam Sterilization

[06942782475734]

Moist Heat or Steam Sterilization

[06942782475734]

Moist Heat or Steam Sterilization

[06942782475734]

Moist Heat or Steam Sterilization

[06942782475734]

Moist Heat or Steam Sterilization

[06942782475734]

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 [Proximal Humeral Locking Plate I]

• 06942782475888: 020962005
• 06942782475734: 020961005