Wallach Endocell

GUDID 00888937011241

Endometrial Cell Sampler

Coopersurgical, Inc.

Endometrial biopsy kit
Primary Device ID00888937011241
NIH Device Record Key62259ef8-353e-40b1-900b-4cef730fe8f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameWallach Endocell
Version Model Number908014A
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100888937011241 [Primary]
GS120888937011245 [Package]
Package: [35 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HFFAspirator, Endometrial

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 Date2016-08-16

On-Brand Devices [Wallach Endocell]

30888937011266Endometrial Cell Sampler
30888937011259Endometrial Cell Sampler
00888937011241Endometrial Cell Sampler

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