Spore Check System

GUDID 00016724410001

Biological Indicator

OSHA REVIEW INC

Biological sterilization indicator
Primary Device ID00016724410001
NIH Device Record Key261b3431-1869-4596-8606-0bc8e1e9d4b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpore Check System
Version Model NumberDual-Spore
Company DUNS944030360
Company NameOSHA REVIEW 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(916) 362-7488
Emailinfo@oshareview.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100016724410001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRCIndicator, Biological Sterilization Process

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-10
Device Publish Date2020-03-02

On-Brand Devices [Spore Check System]

00016724310004Biological Indicator
00016724110000Biological Indicator
00016724410001Biological Indicator

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