Silicone C.W.V. Reservoir

GUDID 04710961934912

FORTUNE MEDICAL INSTRUMENT CORP.

Closed-wound/centesis drainage receptacle
Primary Device ID04710961934912
NIH Device Record Key0b277f91-5e95-4e07-b3e7-1f7f574a1d5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone C.W.V. Reservoir
Version Model Number2013-0940
Company DUNS656763489
Company NameFORTUNE MEDICAL INSTRUMENT CORP.
Device Count5
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
GS104710961934912 [Unit of Use]
GS114710961934919 [Primary]

FDA Product Code

GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered

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 C.W.V. Reservoir]

047109619348372013-0610
047109619349122013-0940
047109619349052013-0920
047109619348992013-0915
047109619348822013-0910
047109619348682013-0640
047109619348512013-0620
047109619348442013-0615

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