Olecranon Locking Plate I 020310004

GUDID 06942782406127

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: 06942782406127
• NIH Device Record Key: a4fa44fb-3f7c-4bf2-85b3-9fe4f072e52d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Olecranon Locking Plate I
• Version Model Number: 020310004
• Catalog Number: 020310004
• 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: 80.8 Millimeter
• Width: 10.1 Millimeter
• Device Size Text, specify: 0
• Length: 80.8 Millimeter
• Width: 10.1 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782406127 [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

[06942782406127]

Moist Heat or Steam Sterilization

[06942782406127]

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 [Olecranon Locking Plate I]

• 06942782406134: 020310008
• 06942782406127: 020310004
• 06942782406110: 020310003
• 06942782405519: 020310007
• 06942782405502: 020310006
• 06942782405496: 020310005