Integron®

GUDID 07798375770293

Moving front chemical integrator with Extender for steam sterilization processes.

TERRAGENE S.A.

Chemical/physical sterilization process indicator
Primary Device ID07798375770293
NIH Device Record Keyb0306587-5bac-4a64-b2e0-6acae816bcf3
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntegron®
Version Model NumberIT26-C
Company DUNS970856911
Company NameTERRAGENE S.A.
Device Count250
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107798164678656 [Primary]
GS107798375770293 [Unit of Use]

FDA Product Code

JOJIndicator, Physical/Chemical Sterilization Process

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-30
Device Publish Date2022-03-22

On-Brand Devices [Integron®]

07798164678151Moving front chemical integrator for steam sterilization processes.
07798164676881Chemical Integrator For Ethylene Oxide sterilization processes.
07798375770293Moving front chemical integrator with Extender for steam sterilization processes.
07798164676034Test pack for Steam sterilization processes.
07798164676904Unique point Integrator Indicator for Steam sterilization processes.
07798164675464Test pack for Steam sterilization processes.
0779816467937025 Test pack for Steam sterilization processes.
0779816467556325 Test pack for Steam sterilization processes.

Trademark Results [Integron]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTEGRON
INTEGRON
88059823 5697021 Live/Registered
Terragene S.A.
2018-07-31
INTEGRON
INTEGRON
79105954 4270257 Dead/Cancelled
Braun GmbH
2011-09-21
INTEGRON
INTEGRON
79067472 3761448 Dead/Cancelled
INTEGRON B.V.
2008-08-13
INTEGRON
INTEGRON
76298105 2585185 Live/Registered
DGA Security Systems, Inc.
2001-08-13
INTEGRON
INTEGRON
75268385 not registered Dead/Abandoned
Ohio State University
1997-04-02
INTEGRON
INTEGRON
75268297 not registered Dead/Abandoned
Ohio State University, The
1997-04-02
INTEGRON
INTEGRON
73823884 1595171 Dead/Cancelled
BECTON, DICKINSON AND COMPANY
1989-09-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.