3.5mm Cortex Screw 040010070

GUDID 06942782411886

Double Medical Technology Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 06942782411886
• NIH Device Record Key: 6ea6eb5a-228a-44fd-a54f-bfee868ad34e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.5mm Cortex Screw
• Version Model Number: 040010070
• Catalog Number: 040010070
• 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: 70 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782411886 [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

[06942782411886]

Moist Heat or Steam Sterilization

[06942782411886]

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 [3.5mm Cortex Screw]

• 06942782412111: 040010008
• 06942782411893: 040010075
• 06942782411886: 040010070
• 06942782411879: 040010065
• 06942782411510: 040010060
• 06942782411503: 040010055
• 06942782408725: 040010050
• 06942782408718: 040010048
• 06942782408701: 040010046
• 06942782408695: 040010045
• 06942782408688: 040010044
• 06942782408671: 040010042
• 06942782408664: 040010040
• 06942782408657: 040010038
• 06942782408640: 040010036
• 06942782408633: 040010034
• 06942782408626: 040010032
• 06942782408619: 040010030
• 06942782408602: 040010028
• 06942782408596: 040010026
• 06942782408589: 040010024
• 06942782408572: 040010022
• 06942782408565: 040010020
• 06942782408558: 040010018
• 06942782408541: 040010016
• 06942782408534: 040010014
• 06942782408527: 040010012
• 06942782408510: 040010010