Excelsior Scientific MSCS-05E

GUDID 00860008246738

Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stearothermophilus ATCC® 7953, at a minimum of 105 bacterial spores encased within a polypropylene cap, and a polypropylene vial which includes a glass ampule hermetically sealed containing a nutrient broth culture medium modified with a pH indicator, Bromocresol Purple For Use in Monitoring steam sterilization cycles at 121C, 30 minutes (Gravity), 132C, 4 minutes (Pre-Vacuum), and 135C 3 minutes (Pre-Vacuum)

True Indicating LLC

Biological sterilization indicator
Primary Device ID00860008246738
NIH Device Record Keyb0d76b47-2be7-4a6f-bc0a-bc76a3ae16ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameExcelsior Scientific
Version Model NumberMSCS-05E
Catalog NumberMSCS-05E
Company DUNS116935598
Company NameTrue Indicating LLC
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 Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com
Phone419-476-7119
Emailinfo@trueindicating.com

Operating and Storage Conditions

Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100860008246738 [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 Date2023-05-08
Device Publish Date2023-04-28

On-Brand Devices [Excelsior Scientific]

00860008246738Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with
00197644183036Instant 20s Indicator consists of a vial, polypropylene cap, a silicone vented cap which serves

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