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 ID: 00860008246738
• NIH Device Record Key: b0d76b47-2be7-4a6f-bc0a-bc76a3ae16ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Excelsior Scientific
• Version Model Number: MSCS-05E
• Catalog Number: MSCS-05E
• 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
• 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 Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Percent (%) Relative Humidity and 30 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008246738 [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: 2023-05-08
• Device Publish Date: 2023-04-28

On-Brand Devices [Excelsior Scientific]

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