Distal Lateral Humeral Locking Plate, Combi-holes 021371007

GUDID 06942782481339

Double Medical Technology Inc.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 06942782481339
• NIH Device Record Key: 8dfb9c90-e693-4e3f-a2e6-5b3ca94994c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Distal Lateral Humeral Locking Plate, Combi-holes
• Version Model Number: 021371007
• Catalog Number: 021371007
• 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
• Phone: +865926087101
• Email: info@double-medical.com
• Phone: +865926087101
• Email: info@double-medical.com
• Phone: +865926087101
• Email: info@double-medical.com
• Phone: +865926087101
• Email: info@double-medical.com
• Phone: +865926087101
• Email: info@double-medical.com
• Phone: +865926087101
• Email: info@double-medical.com
• Phone: +865926087101
• Email: info@double-medical.com
• Phone: +865926087101
• Email: info@double-medical.com
• Phone: +865926087101
• Email: info@double-medical.com
• Phone: +865926087101
• Email: info@double-medical.com

Device Dimensions

• Length: 117 Millimeter
• Width: 11.2 Millimeter
• Device Size Text, specify: 0
• Length: 117 Millimeter
• Width: 11.2 Millimeter
• Device Size Text, specify: 0
• Length: 117 Millimeter
• Width: 11.2 Millimeter
• Device Size Text, specify: 0
• Length: 117 Millimeter
• Width: 11.2 Millimeter
• Device Size Text, specify: 0
• Length: 117 Millimeter
• Width: 11.2 Millimeter
• Device Size Text, specify: 0
• Length: 117 Millimeter
• Width: 11.2 Millimeter
• Device Size Text, specify: 0
• Length: 117 Millimeter
• Width: 11.2 Millimeter
• Device Size Text, specify: 0
• Length: 117 Millimeter
• Width: 11.2 Millimeter
• Device Size Text, specify: 0
• Length: 117 Millimeter
• Width: 11.2 Millimeter
• Device Size Text, specify: 0
• Length: 117 Millimeter
• Width: 11.2 Millimeter
• Device Size Text, specify: 0
• Length: 117 Millimeter
• Width: 11.2 Millimeter
• Device Size Text, specify: 0
• Length: 117 Millimeter
• Width: 11.2 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782481339 [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

[06942782481339]

Moist Heat or Steam Sterilization

[06942782481339]

Moist Heat or Steam Sterilization

[06942782481339]

Moist Heat or Steam Sterilization

[06942782481339]

Moist Heat or Steam Sterilization

[06942782481339]

Moist Heat or Steam Sterilization

[06942782481339]

Moist Heat or Steam Sterilization

[06942782481339]

Moist Heat or Steam Sterilization

[06942782481339]

Moist Heat or Steam Sterilization

[06942782481339]

Moist Heat or Steam Sterilization

[06942782481339]

Moist Heat or Steam Sterilization

[06942782481339]

Moist Heat or Steam Sterilization

[06942782481339]

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 Lateral Humeral Locking Plate, Combi-holes]

• 06942782481421: 021372009
• 06942782481414: 021372008
• 06942782481407: 021372007
• 06942782481391: 021372006
• 06942782481384: 021372005
• 06942782481377: 021372004
• 06942782481360: 021372003
• 06942782481353: 021371009
• 06942782481346: 021371008
• 06942782481339: 021371007
• 06942782481322: 021371006
• 06942782481315: 021371005
• 06942782481308: 021371004
• 06942782481292: 021371003