Distal Lateral Tibial Locking Plate 020192014

GUDID 06902139001405

Double Medical Technology Inc.

Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Primary Device ID06902139001405
NIH Device Record Key5eb3f7ce-1bae-4908-9ea3-f21637ed5590
Commercial Distribution StatusIn Commercial Distribution
Brand NameDistal Lateral Tibial Locking Plate
Version Model Number020192014
Catalog Number020192014
Company DUNS529366055
Company NameDouble Medical Technology Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+865926087101
Emailinfo@double-medical.com
Phone+865926087101
Emailinfo@double-medical.com

Device Dimensions

Device Size Text, specify0
Length239 Millimeter
Width13 Millimeter
Device Size Text, specify0
Length239 Millimeter
Width13 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS106902139001405 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06902139001405]

Moist Heat or Steam Sterilization


[06902139001405]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-01

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06942782406332020191008
06942782406325020191007
06942782406318020191006
06942782406301020191005
06942782406295020191004
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06902139001399020191016
06902139001382020191014

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