1.5S-Mini Locking Screw 030300019

GUDID 06942782468149

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: 06942782468149
• NIH Device Record Key: 3df7e638-302c-4b6a-882d-18140e9e0793
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1.5S-Mini Locking Screw
• Version Model Number: 030300019
• Catalog Number: 030300019
• 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: 19 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 19 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782468149 [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

[06942782468149]

Moist Heat or Steam Sterilization

[06942782468149]

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 Locking Screw]

• 06942782468170: 030300010
• 06942782468163: 030300009
• 06942782468156: 030300006
• 06942782468149: 030300019
• 06942782468132: 030300020
• 06942782468125: 030300018
• 06942782468118: 030300017
• 06942782468101: 030300016
• 06942782468095: 030300015
• 06942782468088: 030300014
• 06942782468071: 030300013
• 06942782468064: 030300012
• 06942782468057: 030300011
• 06942782468040: 030300008
• 06942782468033: 030300007