Getinge Assured Self-Contained Biological Indicator EO 504054000, 6130160671

GUDID 20814434020794

504054000 - Case of 4 boxes of 100 6130160671 - Box of 50

STERITEC PRODUCT MFG. CO., INC.

Biological sterilization indicator
Primary Device ID20814434020794
NIH Device Record Keydecffe2a-f990-4275-b6a3-61b288c33d78
Commercial Distribution StatusIn Commercial Distribution
Brand NameGetinge Assured Self-Contained Biological Indicator EO
Version Model Number504054000, 6130160671
Catalog Number504054000, 6130160671
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

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100814434020790 [Primary]
GS110814434020797 [Package]
Contains: 00814434020790
Package: Box [100 Units]
In Commercial Distribution
GS120814434020794 [Package]
Contains: 10814434020797
Package: Case [4 Units]
In Commercial Distribution
GS130814434020791 [Package]
Contains: 00814434020790
Package: Box [50 Units]
In Commercial Distribution

FDA Product Code

FRCIndicator, Biological 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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