Fixation Sleeve, φ4.2 110310900

GUDID 06902139111852

Double Medical Technology Inc.

Orthopaedic implantation sleeve, reusable

• Primary Device ID: 06902139111852
• NIH Device Record Key: 07bd59e2-6072-400c-a058-dd76d949b7fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fixation Sleeve, φ4.2
• Version Model Number: 110310900
• Catalog Number: 110310900
• Company DUNS: 529366055
• Company Name: Double Medical Technology Inc.
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06902139111852 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131609

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[06902139111852]

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

Devices Manufactured by Double Medical Technology Inc.

• 06902139111791 - Drill Guide for Guide Wire: 2020-04-06
• 06902139111982 - T-Handle with Quick Coupling: 2020-04-06
• 06902139112088 - Tissue Protector: 2020-04-06
• 06902139112125 - Insertion Handle: 2020-04-06
• 06902139111579 - Inserter-Extractor for Tibial Nail: 2019-04-23
• 06902139111807 - Connecting Screw for Inserter-Extractor: 2019-04-23
• 06902139111821 - Connecting Screw, for extracting nails: 2019-04-23
• 06902139111890 - Hammer Guide for Slide Hammer: 2019-04-23