Larr-Test 24 MSCST-05L

GUDID 00860011103493

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 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 ID	00860011103493
NIH Device Record Key	823909fa-ec5b-470e-8520-d60977f46f8c
Commercial Distribution Discontinuation	2026-10-17
Commercial Distribution Status	In Commercial Distribution
Brand Name	Larr-Test 24
Version Model Number	MSCST-05L
Catalog Number	MSCST-05L
Company DUNS	116935598
Company Name	True Indicating LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	true

Customer Support Contacts

Phone	419-476-7119
Email	info@trueindicating.com
Phone	419-476-7119
Email	info@trueindicating.com
Phone	419-476-7119
Email	info@trueindicating.com
Phone	419-476-7119
Email	info@trueindicating.com
Phone	419-476-7119
Email	info@trueindicating.com
Phone	419-476-7119
Email	info@trueindicating.com
Phone	419-476-7119
Email	info@trueindicating.com
Phone	419-476-7119
Email	info@trueindicating.com
Phone	419-476-7119
Email	info@trueindicating.com
Phone	419-476-7119
Email	info@trueindicating.com
Phone	419-476-7119
Email	info@trueindicating.com

Operating and Storage Conditions

Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011103493 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K200970

FDA Product Code

FRC	Indicator, Biological Sterilization Process

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-05-07
Device Publish Date	2024-04-29

On-Brand Devices [Larr-Test 24]

00860008246745	Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with
00860011103400	Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with
00860011103493	Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with