Silicone Y Drainage Tube

GUDID 04710961934448

FORTUNE MEDICAL INSTRUMENT CORP.

Biliary T drain
Primary Device ID04710961934448
NIH Device Record Keyf4e926a0-4d11-481f-8f14-c784103ada33
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone Y Drainage Tube
Version Model Number1920-0016
Company DUNS656763489
Company NameFORTUNE MEDICAL INSTRUMENT CORP.
Device Count10
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104710961934448 [Primary]
GS114710961934445 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCACatheter, Biliary, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-03-25

On-Brand Devices [Silicone Y Drainage Tube]

047109619344861920-0024
047109619344791920-0022
047109619344621920-0020
047109619344551920-0018
047109619344481920-0016
047109619344311920-0014

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