H/S Catheter with Integrated Stylet • 5 French

GUDID 20888937016400

H/S Catheter with Integrated Stylet • 5 French for Hysterosonography and Hysterosalpingography

Coopersurgical, Inc.

Salpingographic catheter
Primary Device ID20888937016400
NIH Device Record Key0d91a50b-d7a4-42fd-a085-17d7d4e3ca20
Commercial Distribution StatusIn Commercial Distribution
Brand NameH/S Catheter with Integrated Stylet • 5 French
Version Model Number61-3005
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 Kittrue
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
GS120888937016400 [Package]
Contains: 60888937016408
Package: [10 Units]
In Commercial Distribution
GS160888937016408 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-10-03

On-Brand Devices [H/S Catheter with Integrated Stylet • 5 French]

20888937016479H/S Catheter with Integrated Stylet • 5 French for Hysterosonography and Hysterosalpingography
20888937016400H/S Catheter with Integrated Stylet • 5 French for Hysterosonography and Hysterosalpingography

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