True Indicating MSCST-05

GUDID 00850064244007

True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stearothermophilus ATCC® 7953, at a minimum of 10^5 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. One box contains 100 SCBIs. 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 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 ID00850064244007
NIH Device Record Key4d06e442-c196-41d7-9565-876b1f13a2f8
Commercial Distribution Discontinuation2026-10-17
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrue Indicating
Version Model NumberMSCST-05
Catalog NumberMSCST-05
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 TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100850064244007 [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 Date2024-05-09
Device Publish Date2024-05-01

On-Brand Devices [True Indicating]

00860008246714True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc
00860011103486True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc
00850064244007True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.