STEAM GAS INDICATOR LABEL SGL-1000

GUDID 50732224710391

Labels that provide a distinct color change when exposed to the appropriate sterilization process

SPS Medical Supply Corp.

Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator
Primary Device ID50732224710391
NIH Device Record Keyac638bf9-a644-4cc3-971f-cc4e82ac0aee
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTEAM GAS INDICATOR LABEL
Version Model NumberSGL-1000
Catalog NumberSGL-1000
Company DUNS194877072
Company NameSPS Medical Supply Corp.
Device Count1000
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)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.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

Device Identifiers

Device Issuing AgencyDevice ID
GS100732224710396 [Unit of Use]
GS110732224710393 [Primary]
GS150732224710391 [Package]
Contains: 10732224710393
Package: roll [10 Units]
In Commercial Distribution

FDA Product Code

JOJIndicator, physical/chemical sterilization process

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-02-19
Device Publish Date2016-11-15

Devices Manufactured by SPS Medical Supply Corp.

10732224720132 - SporView SELF-CONTAINED EO GAS BI2024-03-19 In-office biological indicators for use in monitoring the efficacy of EO Gas processes.
10732224720149 - SporView SELF-CONTAINED EO GAS BI2024-03-19 In-office biological indicators for use in monitoring the efficacy of EO Gas processes.
50732224720017 - PASSPORT MAIL-IN SYSTEM2023-10-09 Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.
50732224720024 - PASSPORT MAIL-IN SYSTEM2023-10-09 Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.
50732224720031 - PassPort MAIL-IN SYSTEM2023-10-09 Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.
50732224720048 - PassPort MAIL-IN SYSTEM2023-10-09 Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.
50732224720796 - PASSPORT PLUS MAIL-IN SYSTEM2023-10-09 Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.
50732224720802 - PASSPORT PLUS MAIL-IN SYSTEM2023-10-09 Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.