Getinge Assured Smart-Read Biological Indicator, Getinge Assured AccuFast 504054100, 61301606636, 61301606637

GUDID 40814434020774

504054100 - Getinge Assured Smart-Read Biological Indicator - 100 ct. 61301606636 - Getinge Assured AccuFast Biological Indicator - 50 ct. 61301606637 - Getinge Assured AccuFast Biological Indicator - 100 ct.

STERITEC PRODUCT MFG. CO., INC.

Biological sterilization indicator
Primary Device ID40814434020774
NIH Device Record Key16c1b023-7675-4fca-a5e7-7526a870a5c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameGetinge Assured Smart-Read Biological Indicator, Getinge Assured AccuFast
Version Model Number504054100, 61301606636, 61301606637
Catalog Number504054100, 61301606636, 61301606637
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
GS100814434020776 [Primary]
GS110814434020773 [Package]
Contains: 00814434020776
Package: Box [100 Units]
In Commercial Distribution
GS120814434020770 [Package]
Contains: 10814434020773
Package: Case [4 Units]
In Commercial Distribution
GS130814434020777 [Package]
Contains: 00814434020776
Package: Box [50 Units]
In Commercial Distribution
GS140814434020774 [Package]
Contains: 00814434020776
Package: Box [100 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

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