Silicone Endo-Drain Kit

GUDID 04710961935810

FORTUNE MEDICAL INSTRUMENT CORP.

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Primary Device ID04710961935810
NIH Device Record Key0508a918-1897-4c37-8a65-598c99000cb6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone Endo-Drain Kit
Version Model Number2015-9610
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
GS104710961935810 [Unit of Use]
GS114710961935817 [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 Date2022-01-17
Device Publish Date2022-01-07

On-Brand Devices [Silicone Endo-Drain Kit]

047111826055512015-9629
047111826055442015-9624
047109619358412015-9621
047109619358342015-9619
047109619358272015-9615
047109619358102015-9610

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