Distal Medial Tibial Locking Plate II 021502014

GUDID 06942782484170

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: 06942782484170
• NIH Device Record Key: 23077fc2-eb41-4a2a-8ea7-cf5451383dd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Distal Medial Tibial Locking Plate II
• Version Model Number: 021502014
• Catalog Number: 021502014
• 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: 238.5 Millimeter
• Width: 13.5 Millimeter
• Device Size Text, specify: 0
• Length: 238.5 Millimeter
• Width: 13.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782484170 [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

[06942782484170]

Moist Heat or Steam Sterilization

[06942782484170]

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 Tibial Locking Plate II]

• 06942782484170: 021502014
• 06942782484163: 021502012
• 06942782484156: 021502010
• 06942782484149: 021502008
• 06942782484132: 021502006
• 06942782484125: 021502004
• 06942782484118: 021501014
• 06942782484101: 021501012
• 06942782484095: 021501010
• 06942782484088: 021501008
• 06942782484071: 021501006
• 06942782484064: 021501004