SPORVIEW SELF-CONTAINED STEAM BI SCS-100

GUDID 10732224720125

For use in biologically monitoring all steam sterilizers

SPS Medical Supply Corp.

Biological sterilization indicator
Primary Device ID10732224720125
NIH Device Record Keydbcb9254-cd7e-41d9-81d7-5bfeff27c2eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPORVIEW SELF-CONTAINED STEAM BI
Version Model NumberSCS-100
Catalog NumberSCS-100
Company DUNS194877072
Company NameSPS Medical Supply Corp.
Device Count100
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-Countertrue

Customer Support Contacts

Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com
Phone+1(585)359-0130
Emailinfo@spsmedical.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Controlled room temperature per USP
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100732224720128 [Unit of Use]
GS110732224720125 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-06-26
Device Publish Date2016-11-15

On-Brand Devices [SPORVIEW SELF-CONTAINED STEAM BI]

10732224721542For use in biologically monitoring all steam sterilizers
10732224721238For use in biologically monitoring all steam sterilizers
10732224720934In-office biological indicators for use in monitoring the efficacy of steam sterilization proces
10732224720927In-office biological indicators for use in monitoring the efficacy of steam sterilization proces
10732224720125For use in biologically monitoring all steam sterilizers
10732224720118For use in biologically monitoring all steam sterilizers

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