Approved MSCST-05SF

GUDID 00860008246769

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 ID00860008246769
NIH Device Record Keye2e004ec-7455-4b32-b958-8f03f153939e
Commercial Distribution StatusIn Commercial Distribution
Brand NameApproved
Version Model NumberMSCST-05SF
Catalog NumberMSCST-05SF
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 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100860008246769 [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

Devices Manufactured by True Indicating LLC

00850064244007 - True Indicating2024-05-09 True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stea
00860011103493 - Larr-Test 242024-05-07 Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stearothermophilus A
00860011103486 - True Indicating2024-04-15 True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stea
00860011103400 - Larr-Test 242023-11-10 Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stearothermophilus A
00860008246707 - Instant 20s Indicator2023-05-22 Instant 20s Indicator consists of a vial, polypropylene cap, a silicone vented cap which serves as a base and a biological table
00197644183036 - Excelsior Scientific2023-05-22 Instant 20s Indicator consists of a vial, polypropylene cap, a silicone vented cap which serves as a base and a biological table
00197644080601 - Sterim2023-05-08 Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stearothermophilus A
00197644533428 - Sterim2023-05-08 Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stearothermophilus A

Trademark Results [Approved]

Mark Image

Registration | Serial
Company
Trademark
Application Date
APPROVED
APPROVED
97797342 not registered Live/Pending
Carolan, Sean
2023-02-16
APPROVED
APPROVED
97649655 not registered Live/Pending
Approved Holdings, LLC
2022-10-26
APPROVED
APPROVED
90616606 not registered Live/Pending
UNITED STATES BOWLING CONGRESS, INC.
2021-03-31
APPROVED
APPROVED
90457414 not registered Live/Pending
Armstrong, Charletta
2021-01-10
APPROVED
APPROVED
88838781 not registered Live/Pending
Stratum Health System, Inc.
2020-03-18
APPROVED
APPROVED
88724519 not registered Live/Pending
American Automobile Association, Inc.
2019-12-12
APPROVED
APPROVED
88134639 not registered Live/Pending
Buckley Sandler LLP
2018-09-27
APPROVED
APPROVED
87726852 not registered Live/Pending
Whole Foods Market IP, L.P.
2017-12-19
APPROVED
APPROVED
87726844 not registered Live/Pending
Whole Foods Market IP, L.P.
2017-12-19
APPROVED
APPROVED
86473702 4781815 Live/Registered
Approved Holdings, LLC
2014-12-08
APPROVED
APPROVED
86123431 not registered Dead/Abandoned
Drive Now Inc.
2013-11-19
APPROVED
APPROVED
81043754 1043754 Dead/Cancelled
B & D Exterminating Co Inc.
0000-00-00
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