4.5mm Locking Screw for Tibial Nail 070070025

GUDID 06942782413859

Double Medical Technology Inc.

Tibia nail, non-sterile

• Primary Device ID: 06942782413859
• NIH Device Record Key: 7fc4ae5e-180f-44b2-9085-61d8b007f498
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4.5mm Locking Screw for Tibial Nail
• Version Model Number: 070070025
• Catalog Number: 070070025
• 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

Device Dimensions

• Device Size Text, specify: 0
• Length: 25 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782413859 [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

[06942782413859]

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 Locking Screw for Tibial Nail]

• 06942782413934: 070070065
• 06942782413927: 070070060
• 06942782413910: 070070055
• 06942782413903: 070070050
• 06942782413897: 070070045
• 06942782413880: 070070040
• 06942782413873: 070070035
• 06942782413866: 070070030
• 06942782413859: 070070025