2.4S-LCP T-Adaption Plate 021120007

GUDID 06942782476083

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	06942782476083
NIH Device Record Key	3d023c83-424d-4c02-be9d-5be0371cbb51
Commercial Distribution Status	In Commercial Distribution
Brand Name	2.4S-LCP T-Adaption Plate
Version Model Number	021120007
Catalog Number	021120007
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	58 Millimeter
Width	6.4 Millimeter
Device Size Text, specify	0
Length	58 Millimeter
Width	6.4 Millimeter
Device Size Text, specify	0

Device Identifiers

Device Issuing Agency	Device ID
GS1	06942782476083 [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

[06942782476083]

Moist Heat or Steam Sterilization

[06942782476083]

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 [2.4S-LCP T-Adaption Plate]

06942782476663	021120003
06942782476083	021120007
06942782454241	021120005