SteriTec Cross-Checks D CI 105

GUDID 10814434020001

STERITEC PRODUCT MFG. CO., INC.

Chemical/physical sterilization process indicator
Primary Device ID10814434020001
NIH Device Record Key53b28ea2-41ac-48c1-909a-c64981d50786
Commercial Distribution StatusIn Commercial Distribution
Brand NameSteriTec Cross-Checks D
Version Model NumberCI 105
Catalog NumberCI 105
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 TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100814434020004 [Primary]
GS110814434020001 [Package]
Contains: 00814434020004
Package: Bag [250 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.

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30814434021231 - Getinge Assured MI Steam Migrating Integrator Strip2020-07-27
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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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