Distal Fibular Locking Plate, Combi-holes 020511006

GUDID 06942782480073

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: 06942782480073
• NIH Device Record Key: ce6d16c3-fd1a-4f71-a482-44a9c02a5585
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Distal Fibular Locking Plate, Combi-holes
• Version Model Number: 020511006
• Catalog Number: 020511006
• 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
• Length: 116.2 Millimeter
• Width: 10.4 Millimeter
• Device Size Text, specify: 0
• Length: 116.2 Millimeter
• Width: 10.4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782480073 [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

[06942782480073]

Moist Heat or Steam Sterilization

[06942782480073]

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 Fibular Locking Plate, Combi-holes]

• 06942782480189: 020512009
• 06942782480172: 020512008
• 06942782480165: 020512007
• 06942782480158: 020512006
• 06942782480141: 020512005
• 06942782480134: 020512004
• 06942782480127: 020512003
• 06942782480110: 020512002
• 06942782480103: 020511009
• 06942782480097: 020511008
• 06942782480080: 020511007
• 06942782480073: 020511006
• 06942782480066: 020511005
• 06942782480059: 020511004
• 06942782480042: 020511003
• 06942782480035: 020511002