4.0mm Cancellous Screw, Fully Threaded 040030026

GUDID 06942782408794

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: 06942782408794
• NIH Device Record Key: 86ae32ae-c683-4061-8f60-f20a54229375
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4.0mm Cancellous Screw, Fully Threaded
• Version Model Number: 040030026
• Catalog Number: 040030026
• 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

• Length: 26 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782408794 [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

[06942782408794]

Moist Heat or Steam Sterilization

[06942782408794]

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 [4.0mm Cancellous Screw, Fully Threaded]

• 06942782412050: 040030034
• 06942782412043: 040030032
• 06942782412036: 040030038
• 06942782412029: 040030036
• 06942782409418: 040030012
• 06942782409401: 040030010
• 06942782408879: 040030060
• 06942782408862: 040030055
• 06942782408855: 040030050
• 06942782408848: 040030045
• 06942782408831: 040030040
• 06942782408824: 040030035
• 06942782408817: 040030030
• 06942782408800: 040030028
• 06942782408794: 040030026
• 06942782408787: 040030024
• 06942782408770: 040030022
• 06942782408763: 040030020
• 06942782408756: 040030018
• 06942782408749: 040030016
• 06942782408732: 040030014