2.0S-Mini Locking Screw 030320018

GUDID 06942782468002

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: 06942782468002
• NIH Device Record Key: b3b32a66-b20a-40ef-a2df-fb31791fd753
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2.0S-Mini Locking Screw
• Version Model Number: 030320018
• Catalog Number: 030320018
• 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: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 18 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782468002 [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

[06942782468002]

Moist Heat or Steam Sterilization

[06942782468002]

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 [2.0S-Mini Locking Screw]

• 06942782470043: 030320030
• 06942782470036: 030320028
• 06942782470029: 030320026
• 06942782470012: 030320024
• 06942782470005: 030320022
• 06942782468026: 030320020
• 06942782468019: 030320019
• 06942782468002: 030320018
• 06942782467999: 030320017
• 06942782467982: 030320016
• 06942782467975: 030320015
• 06942782467968: 030320014
• 06942782467951: 030320013
• 06942782467944: 030320012
• 06942782467937: 030320011
• 06942782467920: 030320010
• 06942782467913: 030320009
• 06942782467906: 030320008
• 06942782467890: 030320007
• 06942782467883: 030320006