4.0mm Cancellous Screw, Half Threaded 040020028

GUDID 06942782411824

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: 06942782411824
• NIH Device Record Key: 8b52b902-f95e-484c-a6f3-033890a0d7d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4.0mm Cancellous Screw, Half Threaded
• Version Model Number: 040020028
• Catalog Number: 040020028
• 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: 28 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 28 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782411824 [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

[06942782411824]

Moist Heat or Steam Sterilization

[06942782411824]

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, Half Threaded]

• 06942782469016: 040020016
• 06942782469009: 040020014
• 06942782412104: 040020038
• 06942782412081: 040020036
• 06942782412074: 040020034
• 06942782412067: 040020032
• 06942782411824: 040020028
• 06942782411817: 040020026
• 06942782411800: 040020024
• 06942782411794: 040020022
• 06942782411787: 040020020
• 06942782411770: 040020018
• 06942782408947: 040020060
• 06942782408930: 040020055
• 06942782408923: 040020050
• 06942782408916: 040020045
• 06942782408909: 040020040
• 06942782408893: 040020035
• 06942782408886: 040020030