Distal Femoral Locking Plate Ⅱ, Combi-holes 021431012

GUDID 06942782481919

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: 06942782481919
• NIH Device Record Key: 78869825-5136-44de-bfe1-0918dd703358
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Distal Femoral Locking Plate Ⅱ, Combi-holes
• Version Model Number: 021431012
• Catalog Number: 021431012
• 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: 302.5 Millimeter
• Width: 15.5 Millimeter
• Device Size Text, specify: 0
• Length: 302.5 Millimeter
• Width: 15.5 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782481919 [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

[06942782481919]

Moist Heat or Steam Sterilization

[06942782481919]

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 Femoral Locking Plate Ⅱ, Combi-holes]

• 06942782481971: 021432013
• 06942782481964: 021432012
• 06942782481957: 021432010
• 06942782481940: 021432008
• 06942782481933: 021432006
• 06942782481926: 021431013
• 06942782481919: 021431012
• 06942782481902: 021431010
• 06942782481896: 021431008
• 06942782481889: 021431006
• 06942782480714: 021432011
• 06942782480707: 021432009
• 06942782480691: 021432007
• 06942782480684: 021432005
• 06942782480677: 021431011
• 06942782480660: 021431009
• 06942782480653: 021431007
• 06942782480646: 021431005