Distal Clavicular Locking Plate, Combi-holes 020662003

GUDID 06942782452025

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: 06942782452025
• NIH Device Record Key: 7c30ce97-cc00-44d7-93f1-5a0e3b0f7a5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Distal Clavicular Locking Plate, Combi-holes
• Version Model Number: 020662003
• Catalog Number: 020662003
• 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: 52.7 Millimeter
• Width: 10 Millimeter
• Device Size Text, specify: 0
• Length: 52.7 Millimeter
• Width: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782452025 [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

[06942782452025]

Moist Heat or Steam Sterilization

[06942782452025]

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 [Distal Clavicular Locking Plate, Combi-holes]

• 06942782452070: 020662008
• 06942782452063: 020662007
• 06942782452056: 020662006
• 06942782452049: 020662005
• 06942782452032: 020662004
• 06942782452025: 020662003
• 06942782452018: 020661008
• 06942782452001: 020661007
• 06942782451998: 020661006
• 06942782451981: 020661005
• 06942782451974: 020661004
• 06942782451967: 020661003