Tuttnauer®

GUDID 07798375770217

Self-contained Biological Indicator for monitoring steam sterilization processes

TERRAGENE S.A.

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 Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator

• Primary Device ID: 07798375770217
• NIH Device Record Key: 49cd9a11-7e1e-4770-ba30-e014ff68b173
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tuttnauer®
• Version Model Number: WTL198-0058
• Company DUNS: 970856911
• Company Name: TERRAGENE S.A.
• Device Count: 25
• 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: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com
• Phone: +5493415587007
• Email: info@terragene.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	07798164677444 [Primary]
GS1	07798164677505 [Primary]
GS1	07798375770217 [Unit of Use]

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: 2022-03-29
• Device Publish Date: 2022-03-21

On-Brand Devices [Tuttnauer®]

• 07798375770217: Self-contained Biological Indicator for monitoring steam sterilization processes
• 07798164677468: Auto-Reader Incubator for biological indicators
• 07798164677376: Steam Test Pack PCD Kit (25 test packs and 25 control BIs)
• 07798375770248: Chemical indicator strip for monitoring hydrogen peroxide sterilization processes.
• 07798375770231: Moving front chemical integrator for steam sterilization processes.
• 07798375770286: Self-contained Biological Indicator for monitoring hydrogen peroxide sterilization processes
• 07798375770262: Self-contained Biological Indicator for monitoring hydrogen peroxide sterilization processes
• 07798164677666: Unique point Integrator Indicator for Steam sterilization processes.
• 07798164677697: Indicator Tape For Plasma or Vaporized Hydrogen Peroxide sterilization processes
• 07798375770279: Self-contained Biological Indicator for monitoring steam sterilization processes
• 07798375770255: Multivariable process indicator for monitoring Steam sterilization processes
• 07798164677390: Steam Test Pack PCD Kit (25 test packs and 25 control BIs)
• 07798164677352: Super Adherent Indicator Tape For Steam sterilization processes.
• 07798164677475: Auto-Reader Incubator for biological indicators