H/S Procedure Tray • 7 French • Integrated Stylet

GUDID 20888937016431

H/S Procedure Tray • 7 French • Integrated Stylet for Hysterosonography and Hysterosalpingography

Coopersurgical, Inc.

Fallopian tube catheterization kit
Primary Device ID20888937016431
NIH Device Record Keyf1796ba0-0cf7-4834-87e7-eeb695ae4e5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameH/S Procedure Tray • 7 French • Integrated Stylet
Version Model Number61-3207
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
GS120888937016431 [Package]
Contains: 60888937016439
Package: [10 Units]
In Commercial Distribution
GS160888937016439 [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 Date2017-10-04

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