1.5S-Mini Screw 030070010

GUDID 06942782410148

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: 06942782410148
• NIH Device Record Key: a65a8b46-b302-49dd-b4ae-b1a09dd8e9d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1.5S-Mini Screw
• Version Model Number: 030070010
• Catalog Number: 030070010
• 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: 10 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782410148 [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

[06942782410148]

Moist Heat or Steam Sterilization

[06942782410148]

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 [1.5S-Mini Screw]

• 06942782410247: 030070020
• 06942782410230: 030070019
• 06942782410223: 030070018
• 06942782410216: 030070017
• 06942782410209: 030070016
• 06942782410193: 030070015
• 06942782410186: 030070014
• 06942782410179: 030070013
• 06942782410162: 030070012
• 06942782410155: 030070011
• 06942782410148: 030070010
• 06942782410131: 030070009
• 06942782410124: 030070008
• 06942782410117: 030070007
• 06942782410100: 030070006