Sporview 10 Hour Self Contained BI SVT-504

GUDID 00732224721484

For use in biologically monitoring steam sterilizers

CROSSTEX INTERNATIONAL, INC.

Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator
Primary Device ID00732224721484
NIH Device Record Keye1fa183f-a2a2-43f2-b3b6-ed583f48164c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSporview 10 Hour Self Contained BI
Version Model NumberSVT-504
Catalog NumberSVT-504
Company DUNS057728685
Company NameCROSSTEX INTERNATIONAL, INC.
Device Count4
DM Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0130
Emailregulatoryaffairs@hu-friedy.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100732224721484 [Unit of Use]
GS150732224721489 [Primary]

FDA Product Code

FRCIndicator, biological sterilization process

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-18
Device Publish Date2024-04-10

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