SteriTec Smart-Read Steam 10^6 Biologocal Indicator EZSR-6

GUDID 10814434020544

STERITEC PRODUCT MFG. CO., INC.

Biological sterilization indicator Biological sterilization indicator
Primary Device ID10814434020544
NIH Device Record Key38ed9c69-b181-48db-ba0a-7b9a535bf5b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSteriTec Smart-Read Steam 10^6 Biologocal Indicator
Version Model NumberEZSR-6
Catalog NumberEZSR-6
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
GS100814434020547 [Primary]
GS110814434020544 [Package]
Contains: 00814434020547
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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