Silicone T Drainage Set

GUDID 04711182613020

FORTUNE MEDICAL INSTRUMENT CORP.

Biliary T drain
Primary Device ID04711182613020
NIH Device Record Key15171a01-7cac-4d58-9232-7adf5411a61d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone T Drainage Set
Version Model Number1910-8018
Company DUNS656763489
Company NameFORTUNE MEDICAL INSTRUMENT CORP.
Device Count5
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
GS104711182613020 [Primary]
GS114711182613027 [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 Date2016-03-24

On-Brand Devices [Silicone T Drainage Set]

047111826130511910-8012
047111826130441910-8014
047111826130371910-8016
047111826130201910-8018
047111826130131910-8020
047111826130061910-8022
047111826129931910-8024

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