Dual Species BI Strip DS-100-RED

GUDID 00732224720197

Geobacillus stearothermophilus and Bacillus atrophaeus for EO Gas, Steam, Dry Heat and Chemical Vapor sterilization processes

CROSSTEX INTERNATIONAL, INC.

Biological sterilization indicator
Primary Device ID00732224720197
NIH Device Record Key2511123a-24b2-4f87-9081-92c2d06279a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameDual Species BI Strip
Version Model NumberDS-100-RED
Catalog NumberDS-100-RED
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
GS100732224720197 [Unit of Use]
GS110732224720194 [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 [Dual Species BI Strip]

00732224720159Dual Spore Strip, Geobacillus stearothermophilus and Bacillus atrophaeus
00732224720203Geobacillus stearothermophilus and Bacillus atrophaeus for EO Gas, Steam, Dry Heat and Chemical
00732224720197Geobacillus stearothermophilus and Bacillus atrophaeus for EO Gas, Steam, Dry Heat and Chemical
00732224720180Geobacillus stearothermophilus and Bacillus atrophaeus for EO Gas, Steam, Dry Heat and Chemical
00732224720173Geobacillus stearothermophilus and Bacillus atrophaeus for EO Gas, Steam, Dry Heat and Chemical
00732224720166Geobacillus stearothermophilus and Bacillus atrophaeus for EO Gas, Steam, Dry Heat and Chemical

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