Distal Humeral Sub-Condylar Locking Plate, Combi-h 020621004

GUDID 06942782452421

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: 06942782452421
• NIH Device Record Key: 533bdb33-f0cf-497e-a642-8b0ddc240194
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Distal Humeral Sub-Condylar Locking Plate, Combi-h
• Version Model Number: 020621004
• Catalog Number: 020621004
• 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

• Length: 95.5 Millimeter
• Width: 12 Millimeter
• Device Size Text, specify: 0
• Length: 95.5 Millimeter
• Width: 12 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782452421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130108

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[06942782452421]

Moist Heat or Steam Sterilization

[06942782452421]

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 Humeral Sub-Condylar Locking Plate, Combi-h]

• 06942782452476: 020622010
• 06942782452469: 020622007
• 06942782452452: 020622004
• 06942782452445: 020621010
• 06942782452438: 020621007
• 06942782452421: 020621004