Proximal Femoral Locking Plate, Combi-holes 020422004

GUDID 06942782479077

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: 06942782479077
• NIH Device Record Key: ab6c6558-5cd2-4383-8838-7d6d18bccb90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Proximal Femoral Locking Plate, Combi-holes
• Version Model Number: 020422004
• Catalog Number: 020422004
• 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: 17.6 Millimeter
• Length: 164.7 Millimeter
• Device Size Text, specify: 0
• Width: 17.6 Millimeter
• Length: 164.7 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782479077 [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

[06942782479077]

Moist Heat or Steam Sterilization

[06942782479077]

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 [Proximal Femoral Locking Plate, Combi-holes]

• 06942782479121: 020422013
• 06942782479114: 020422012
• 06942782479107: 020422010
• 06942782479091: 020422008
• 06942782479084: 020422006
• 06942782479077: 020422004
• 06942782479060: 020422003
• 06942782479053: 020421013
• 06942782479046: 020421012
• 06942782479039: 020421010
• 06942782479022: 020421008
• 06942782479015: 020421006
• 06942782479008: 020421004
• 06942782478995: 020421003
• 06942782478384: 020422011
• 06942782478377: 020422009
• 06942782478360: 020422007
• 06942782478353: 020422005
• 06942782478346: 020421011
• 06942782478339: 020421009
• 06942782478322: 020421007
• 06942782478315: 020421005