GyneCath Catheter • 5F

GUDID 30888937016551

GyneCath Catheter • 5F for Hysterosonography and Hysterosalpingography

Coopersurgical, Inc.

Salpingographic catheter
Primary Device ID30888937016551
NIH Device Record Keyc0371261-4bc8-48f8-9b69-bbb464fe8a4b
Commercial Distribution StatusIn Commercial Distribution
Brand NameGyneCath Catheter • 5F
Version Model Number19610
Company DUNS801895244
Company NameCoopersurgical, Inc.
Device Count1
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100888937016550 [Primary]
GS120888937016554 [Package]
Contains: 00888937016550
Package: [10 Units]
In Commercial Distribution
GS130888937016551 [Package]
Contains: 20888937016554
Package: [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKFCannula, Manipulator/Injector, Uterine

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-22

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