Silicone Flat Drain Kit

GUDID 04710961935070

FORTUNE MEDICAL INSTRUMENT CORP.

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Primary Device ID04710961935070
NIH Device Record Key5009c483-7f85-4150-bc12-c11af12b3f0a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone Flat Drain Kit
Version Model Number2014-9101
Company DUNS656763489
Company NameFORTUNE MEDICAL INSTRUMENT CORP.
Device Count10
DM Exemptfalse
Pre-market Exempttrue
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104710961935070 [Unit of Use]
GS114710961935077 [Primary]

FDA Product Code

GCDConnector, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-08
Device Publish Date2022-01-31

On-Brand Devices [Silicone Flat Drain Kit]

047109619351002014-9132
047109619350942014-9131
047109619350872014-9102
047109619350702014-9101
047109619350632014-9072
047109619350562014-9071
047109619350492014-9052
047109619350322014-9051

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