Distal Humeral Sub-Condylar Locking Plate, Combi-h 020622010

GUDID 06942782452476

Double Medical Technology Inc.

Orthopaedic fixation plate, non-bioabsorbable, non-sterile Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Primary Device ID06942782452476
NIH Device Record Key59dc810a-607c-4baf-bf25-26ea3c3419f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameDistal Humeral Sub-Condylar Locking Plate, Combi-h
Version Model Number020622010
Catalog Number020622010
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
Width12 Millimeter
Length188.5 Millimeter
Device Size Text, specify0
Width12 Millimeter
Length188.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS106942782452476 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06942782452476]

Moist Heat or Steam Sterilization


[06942782452476]

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

On-Brand Devices [Distal Humeral Sub-Condylar Locking Plate, Combi-h]

06942782452476020622010
06942782452469020622007
06942782452452020622004
06942782452445020621010
06942782452438020621007
06942782452421020621004

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