SEALSURE™

GUDID 07798375772242

SEALSURE™ Steam Indicator Tape 18mm

TERRAGENE S.A.

Chemical/physical sterilization process indicator
Primary Device ID07798375772242
NIH Device Record Key62c0ef6e-1875-4bfb-ab35-db34ffb53cf5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSEALSURE™
Version Model Number73170
Company DUNS970856911
Company NameTERRAGENE S.A.
Device Count1
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+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.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

Device Identifiers

Device Issuing AgencyDevice ID
GS107798375772242 [Package]
Contains: 07798375772303
Package: Case [4 Units]
In Commercial Distribution
GS107798375772303 [Primary]

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 Date2023-11-21
Device Publish Date2023-11-13

Devices Manufactured by TERRAGENE S.A.

07798375772228 - VERISURE™2023-11-21 VERISURE™ Steam Type 5 Migrating Integrator w/ Extender
07798375772198 - VERISURE™2023-11-21 VERISURE™ Bowie-Dick Test Pack
07798375772211 - VERISURE™2023-11-21 VERISURE™ Steam Type 5 Migrating Integrator
07798375772235 - VERISURE™2023-11-21 VERISURE™ Steam Type 5 Migrating Integrator Process Challenge Device
07798375772242 - SEALSURE™2023-11-21SEALSURE™ Steam Indicator Tape 18mm
07798375772242 - SEALSURE™2023-11-21 SEALSURE™ Steam Indicator Tape 18mm
07798375772457 - BIOTRACE™2023-11-21 BIOTRACE™ Auto Read 20 Steam Biological Indicator
07798375772464 - BIOTRACE™2023-11-21 BIOTRACE™ Auto Read 20 Steam BI Process Challenge Device
07798375772471 - BIOTRACE™2023-11-21 BIOTRACE™ Auto Read Pro Biological Indicator Reader.

Trademark Results [SEALSURE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SEALSURE
SEALSURE
75934729 2810943 Live/Registered
JOHNSON & JOHNSON
2000-03-03

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