Getinge Steam Sterilization Integrator 61301658261, 61301600556

GUDID 20814434020589

61301658261 - Bag of 250 Integrators 61301600556 - Bag of 100 Integrators

STERITEC PRODUCT MFG. CO., INC.

Chemical/physical sterilization process indicator
Primary Device ID20814434020589
NIH Device Record Keyf13c9de1-e042-4375-ab8e-28fea0aab3f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameGetinge Steam Sterilization Integrator
Version Model Number61301658261, 61301600556
Catalog Number61301658261, 61301600556
Company DUNS622223196
Company NameSTERITEC PRODUCT MFG. CO., INC.
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-Counterfalse

Operating and Storage Conditions

Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 35 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100814434020585 [Primary]
GS110814434020582 [Package]
Contains: 00814434020585
Package: Bag [250 Units]
In Commercial Distribution
GS120814434020589 [Package]
Contains: 00814434020585
Package: Bag [100 Units]
In Commercial Distribution

FDA Product Code

JOJIndicator, Physical/Chemical Sterilization Process

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-23

Devices Manufactured by STERITEC PRODUCT MFG. CO., INC.

10814434020803 - SteriTec Green Tape 3/4"2022-06-17
10814434021312 - SteriTec Green Tape 1"2022-06-17
10814434021633 - Getinge Assured Green Tape 3/4"2022-06-17
10814434021640 - Getinge Assured Green Tape 1"2022-06-17
30814434021231 - Getinge Assured MI Steam Migrating Integrator Strip2020-07-27
10732224109265 - Crosstex International2020-05-06 Sure Check Strip
20814434020619 - Getinge Pack Self-Seal Sterilization Pouch 9cm x 13cm2019-11-08
20814434020626 - Getinge Pack Self-Seal Sterilization Pouch 9cm x 23cm2019-11-08

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