Tuttnauer®

GUDID 07798375770217

Self-contained Biological Indicator for monitoring steam sterilization processes

TERRAGENE S.A.

Biological sterilization indicator
Primary Device ID07798375770217
NIH Device Record Key49cd9a11-7e1e-4770-ba30-e014ff68b173
Commercial Distribution StatusIn Commercial Distribution
Brand NameTuttnauer®
Version Model NumberWTL198-0058
Company DUNS970856911
Company NameTERRAGENE S.A.
Device Count25
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

Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com
Phone+5493415587007
Emailinfo@terragene.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS107798164677444 [Primary]
GS107798164677505 [Primary]
GS107798375770217 [Unit of Use]

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 Date2022-03-29
Device Publish Date2022-03-21

On-Brand Devices [Tuttnauer®]

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

Trademark Results [Tuttnauer]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TUTTNAUER
TUTTNAUER
74226292 1717852 Live/Registered
TUTTNAUER USA COMPANY, LTD.
1991-11-29

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