Distal Medial Humeral Locking Plate, Combi-holes 021382008

GUDID 06942782481544

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: 06942782481544
• NIH Device Record Key: 674b58e6-6d41-41e8-8a1c-b8674efbdfeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Distal Medial Humeral Locking Plate, Combi-holes
• Version Model Number: 021382008
• Catalog Number: 021382008
• 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: 123 Millimeter
• Width: 11.2 Millimeter
• Device Size Text, specify: 0
• Length: 123 Millimeter
• Width: 11.2 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782481544 [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

[06942782481544]

Moist Heat or Steam Sterilization

[06942782481544]

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 Humeral Locking Plate, Combi-holes]

• 06942782481551: 021382009
• 06942782481544: 021382008
• 06942782481537: 021382007
• 06942782481520: 021382006
• 06942782481513: 021382005
• 06942782481506: 021382004
• 06942782481490: 021382003
• 06942782481483: 021381009
• 06942782481476: 021381008
• 06942782481469: 021381007
• 06942782481452: 021381006
• 06942782481445: 021381005
• 06942782481438: 021381003
• 06942782480486: 021381004