StemTrol Control Cells IM3632

GUDID 15099590220020

StemTrol Control Cells

Beckman Coulter, Inc.

Fixative, Orth's solution
Primary Device ID15099590220020
NIH Device Record Keydeec179f-c2cd-4103-8c24-8f40f7285e8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameStemTrol Control Cells
Version Model NumberIM3632
Catalog NumberIM3632
Company DUNS008254708
Company NameBeckman Coulter, 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 Datetrue
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
GS115099590220020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKZCounter, Differential Cell

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [StemTrol Control Cells]

15099590220020StemTrol Control Cells
15099590762896StemTrol Control Cells

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