Distal Femoral Locking Plate I, Combi-holes 020431008

GUDID 06942782479152

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: 06942782479152
• NIH Device Record Key: d5f36c08-1c57-4421-b53c-c138dde8e0b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Distal Femoral Locking Plate I, Combi-holes
• Version Model Number: 020431008
• Catalog Number: 020431008
• 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

• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 219.7 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Length: 219.7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782479152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130108

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[06942782479152]

Moist Heat or Steam Sterilization

[06942782479152]

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 I, Combi-holes]

• 06942782479244: 020432013
• 06942782479237: 020432012
• 06942782479220: 020432010
• 06942782479213: 020432008
• 06942782479206: 020432006
• 06942782479190: 020432004
• 06942782479183: 020431013
• 06942782479176: 020431012
• 06942782479169: 020431010
• 06942782479152: 020431008
• 06942782479145: 020431006
• 06942782479138: 020431004
• 06942782478469: 020432011
• 06942782478452: 020432009
• 06942782478445: 020432007
• 06942782478438: 020432005
• 06942782478421: 020431011
• 06942782478414: 020431009
• 06942782478407: 020431007
• 06942782478391: 020431005