Single Species BI Strip BS-107

GUDID 00732224720289

Geobacillus stearothermophilus 10e7 strip for Steam sterilization processes

CROSSTEX INTERNATIONAL, INC.

Biological sterilization indicator
Primary Device ID00732224720289
NIH Device Record Key05d9afb9-e231-479d-b4d9-a4bf3c400692
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle Species BI Strip
Version Model NumberBS-107
Catalog NumberBS-107
Company DUNS057728685
Company NameCROSSTEX INTERNATIONAL, INC.
Device Count100
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100732224720289 [Unit of Use]
GS110732224720286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2024-04-04
Device Publish Date2024-03-27

On-Brand Devices [Single Species BI Strip]

00732224720432Bacillus atrophaeus 10e6 strip for EO Gas and Dry Heat sterilization processes
00732224720333Bacillus atrophaeus 10e8 strip for EO Gas and Dry Heat sterilization processes
00732224720326Bacillus atrophaeus 10e7 strip for EO Gas and Dry Heat sterilization processes
00732224720319Bacillus atrophaeus 10e6 strip for EO Gas and Dry Heat sterilization processes
00732224720302Bacillus atrophaeus 10e6 strip for Dry Heat sterilization processes
00732224720296Geobacillus stearothermophilus 10e8 strip for Steam sterilization processes
00732224720289Geobacillus stearothermophilus 10e7 strip for Steam sterilization processes
00732224720272Geobacillus stearothermophilus 10e6 strip for Steam sterilization processes
00732224720234Geobacillus stearothermophilus 10e5 strip for Steam sterilization processes
00732224720227Geobacillus stearothermophilus 10e6 strip for Steam sterilization processes
00732224720210Geobacillus stearothermophilus 10e5 strip for Steam sterilization processes

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