H/S Procedure Tray • 7 French

GUDID 20888937016509

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

Coopersurgical, Inc.

Fallopian tube catheterization kit
Primary Device ID20888937016509
NIH Device Record Key3c265053-cc93-4a95-a3ce-ef0b640f2eef
Commercial Distribution StatusIn Commercial Distribution
Brand NameH/S Procedure Tray • 7 French
Version Model Number61-5207
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
GS120888937016509 [Package]
Contains: 60888937016507
Package: [10 Units]
In Commercial Distribution
GS160888937016507 [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

Devices Manufactured by Coopersurgical, Inc.

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60888937027176 - ERPeak2024-04-18 IVD Sample kit
60888937027183 - ERPeak2024-04-18 IVD Sample kit
60888937027190 - ERPeak2024-04-18 IVD Sample kit
60888937027206 - ERPeak2024-04-18 IVD Sample kit
00888937026870 - Mara Console2024-03-21 Mara Console- Endometrial Ablation
00888937023817 - K-Systems2024-02-27 L126 IVF, Standard Heat Right

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