Tuttnauer®
GUDID 07798375770279
Self-contained Biological Indicator for monitoring steam sterilization processes
TERRAGENE S.A.
Biological sterilization indicator| Primary Device ID | 07798375770279 |
| NIH Device Record Key | 8087e6c6-23ae-419d-9de1-fbe6fcf2cf67 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tuttnauer® |
| Version Model Number | WTL198-0072 |
| 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 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| info@terragene.com | |
| Phone | +5493415587007 |
| 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 |
| 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 | 07798164677437 [Primary] |
| GS1 | 07798164677512 [Primary] |
| GS1 | 07798375770279 [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 | 2022-04-01 |
| Device Publish Date | 2022-03-24 |
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 |
Trademark Results [Tuttnauer]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TUTTNAUER 74226292 1717852 Live/Registered |
TUTTNAUER USA COMPANY, LTD. 1991-11-29 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.