4.5mm Cortex Screw 040040042

GUDID 06942782408114

Double Medical Technology Inc.

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

• Primary Device ID: 06942782408114
• NIH Device Record Key: d4cc49b1-1090-4e1b-9f90-4806352eb39c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4.5mm Cortex Screw
• Version Model Number: 040040042
• Catalog Number: 040040042
• 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: 42 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 42 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782408114 [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

[06942782408114]

Moist Heat or Steam Sterilization

[06942782408114]

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 [4.5mm Cortex Screw]

• 06942782411565: 040040076
• 06942782411558: 040040072
• 06942782411541: 040040070
• 06942782409432: 040040020
• 06942782409425: 040040018
• 06942782408244: 040040068
• 06942782408237: 040040066
• 06942782408220: 040040064
• 06942782408213: 040040062
• 06942782408206: 040040060
• 06942782408190: 040040058
• 06942782408183: 040040056
• 06942782408176: 040040054
• 06942782408169: 040040052
• 06942782408152: 040040050
• 06942782408145: 040040048
• 06942782408138: 040040046
• 06942782408121: 040040044
• 06942782408114: 040040042
• 06942782408107: 040040040
• 06942782408091: 040040038
• 06942782408084: 040040036
• 06942782408077: 040040034
• 06942782408060: 040040032
• 06942782408053: 040040030
• 06942782408046: 040040028
• 06942782408039: 040040026
• 06942782408022: 040040024
• 06942782408015: 040040022