Distal Medial Tibial Locking Plate, Combi-holes 020451004

GUDID 06942782479404

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: 06942782479404
• NIH Device Record Key: 2e86b2ae-bb1f-4aa9-b742-a99757690b06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Distal Medial Tibial Locking Plate, Combi-holes
• Version Model Number: 020451004
• Catalog Number: 020451004
• 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

• Width: 14 Millimeter
• Length: 129.75 Millimeter
• Device Size Text, specify: 0
• Width: 14 Millimeter
• Length: 129.75 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782479404 [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

[06942782479404]

Moist Heat or Steam Sterilization

[06942782479404]

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 Medial Tibial Locking Plate, Combi-holes]

• 06942782479510: 020452012
• 06942782479503: 020452010
• 06942782479497: 020452008
• 06942782479480: 020452006
• 06942782479473: 020452004
• 06942782479466: 020452003
• 06942782479442: 020451012
• 06942782479435: 020451010
• 06942782479428: 020451008
• 06942782479411: 020451006
• 06942782479404: 020451004
• 06942782479398: 020451003
• 06942782478629: 020452011
• 06942782478612: 020452009
• 06942782478605: 020452007
• 06942782478599: 020452005
• 06942782478582: 020451011
• 06942782478575: 020451009
• 06942782478568: 020451007
• 06942782478551: 020451005