3.5mm Locking Screw, Self-tapping 040070048

GUDID 06942782411459

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: 06942782411459
• NIH Device Record Key: 52092361-048a-42b6-aec2-b56cf74b9e68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3.5mm Locking Screw, Self-tapping
• Version Model Number: 040070048
• Catalog Number: 040070048
• 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: 48 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 48 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782411459 [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

[06942782411459]

Moist Heat or Steam Sterilization

[06942782411459]

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 [3.5mm Locking Screw, Self-tapping]

• 06942782466756: 040070056
• 06942782466749: 040070054
• 06942782466732: 040070058
• 06942782466725: 040070046
• 06942782466718: 040070044
• 06942782411466: 040070052
• 06942782411459: 040070048
• 06942782411442: 040070042
• 06942782411435: 040070038
• 06942782411428: 040070036
• 06942782411411: 040070034
• 06942782411404: 040070032
• 06942782410421: 040070060
• 06942782410414: 040070055
• 06942782409586: 040070050
• 06942782409579: 040070045
• 06942782409562: 040070040
• 06942782409555: 040070035
• 06942782409548: 040070030
• 06942782409531: 040070028
• 06942782409524: 040070026
• 06942782409517: 040070024
• 06942782409500: 040070022
• 06942782409494: 040070020
• 06942782409487: 040070018
• 06942782409470: 040070016
• 06942782409463: 040070014
• 06942782409456: 040070012
• 06942782409449: 040070010