FDA.reportPublic FDA data

SPOROX®

Primary DI
D687751951
Brand
SPOROX®
Company
Sultan Healthcare Inc
Model
75195
Device description
Sporox® Test Vials - Contains: 30 test vials, 1 bottle of indicator solution, 1 solution dropper, 30 replacement tips
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOJIndicator, physical/chemical sterilization process
MEDSterilant, medical devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2
MEDSterilant, Medical DevicesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6870075195FG2PackageHIBCC4In Commercial Distribution
D687751951PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hydrogen peroxide device sterilantA gaseous or liquid substance that includes hydrogen peroxide (H2O2) as its primary agent to completely destroy or eliminate all harmful microorganisms on a medical device (e.g., surgical or dental instrument). The medical device is typically bathed by the substance for a specified period of time in order to achieve sterilization. The substance may be presented in discrete quantities to accommodate the requirements of a sterilization device or system. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep in a clean dry location.
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)989-8825xx@xx.xx

Regulatory Flags#

DUNS number
056296981
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D6870031103FG1Durashield® CV0031103FG2016-09-23
D6870031104FG1Durashield® CV0031104FG2016-09-23
D6870031105FG1Durashield® CV0031105FG2016-09-23
D6870031106FG1Durashield® CV0031106FG2016-09-23
D6870020361SA1Com-Fit0020361SA2017-07-18
D687215001Cleanlets21500215002022-11-30
D687215051Cleanlets21505215052022-11-30
D687215201ReSURGE™ 21520215202022-12-05
D687AD320121Topex® AD32012AD320122022-12-05
D687AD33004FG13-WayAD33000FGAD33004FG2022-12-05
D687215200ReSURGE™ 21520215202022-12-05
D687215211ReSURGE™ 21521215212022-12-05
D687AD320120Topex® AD32012AD320122022-12-05
D687AD33004FG03-WayAD33000FGAD33004FG2022-12-05
D687AD320101Topex® AD32010AD320102022-12-03
D687AD320111Topex® AD32010AD320112022-12-03
D687AD320131Topex® AD32010AD320132022-12-03
D687AD321011Topex® AD32010AD321012022-12-03
D687AD321021Topex® AD32010AD321022022-12-03
D687AD321031Topex® AD32010AD321032022-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840456206898JMUJMU DENTAL, INCJOJ2026-07-08
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15056030400688Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
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25056030403853Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
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25056030403877Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403884Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
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25056030403907Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
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25056030403921Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403938Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403945Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403952Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
00840456201053JMUJMU DENTAL, INCJOJ2026-06-05
00840456201060JMUJMU DENTAL, INCJOJ2026-06-05
00840456201077JMUJMU DENTAL, INCJOJ2026-06-05
00840456201275JMUJMU DENTAL, INCJOJ2026-06-05
00840456201282JMUJMU DENTAL, INCJOJ2026-06-05
00840456201299JMUJMU DENTAL, INCJOJ2026-06-05
00840456201305JMUJMU DENTAL, INCJOJ2026-06-05
00840456201312JMUJMU DENTAL, INCJOJ2026-06-05