FDA.reportPublic FDA data

STERIDENT

Primary DI
B234FRGSTMS400634
Brand
STERIDENT
Company
CPAC EQUIPMENT, INC.
Model
400634
Device description
SPORE TEST KIT MONITORING SERVICE DRY HEAT OR STEAM, MAIL IN 52/BOX
Published
2018-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FRCIndicator, Biological Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRCIndicator, Biological Sterilization ProcessGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023716000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023716000SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIPSpsmedical Supply Corp.2002-12-05FRC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B234FRGSTMS400634PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Biological sterilization indicatorA sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
601985976
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B234FRGDHIS400635STERIDENT4006352018-09-20
B234KMHRHPRO111230V1RH-Pro11-230VRH-PRo11-230V2020-10-01
B234KMHRHPRO9115V3RH-Pro9RH-Pro92020-10-01
B234KMHRHPRO9115V4RH-Pro9-230VRH-Pro9-230V2020-10-01
B234FRGSSNP400636STERIDENT4006362018-08-31
B234FRGSSNP400637STERIDENT4006372018-08-31
B234FRGSSNP400638STERIDENT4006382018-08-31
B234FRGSSNP400639STERIDENT4006392018-08-31
B234FRGSSNP400651STERIDENT4006512018-08-31
B234JCXPD101008115PORTODENT1010082018-08-31
B234JCXPD101009230PORTODENT1010092018-08-31
B234JCXPD101125115PORTODENT1011252018-08-31
B234KMHCX6000115V150COX RAPIDHEAT6000COX-115V-152018-07-31
B234KMHCX6000115V161COX RAPIDHEAT6000-16COX-115V-162018-08-23
B234KMHCX6220230V152COX RAPIDHEAT6220COX-230V-152018-08-24
B234KMHCX6220230V163COX RAPIDHEAT6220COX-230V-162018-08-24
B234KMHRHPRO111115V0RH-Pro11RH-Pro112019-01-18
B234KMHSD201000115STERIDENT2002018-08-31
B234KMHSD201000230STERIDENT2002018-08-31
B234KMHSD301000115STERIDENT3002018-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
107073878129323M™ Attest™3M COMPANYFRC2026-04-26
107073878129563M™ Attest™3M COMPANYFRC2026-04-26
307073875085563M™ Attest™3M COMPANYFRC2026-04-26
107073878151173M™ Attest™3M COMPANYFRC2026-04-10
107073878151243M™ Attest™3M COMPANYFRC2026-04-10
307073878129123M™ Attest™3M COMPANYFRC2026-04-10
307073878129363M™ Attest™3M COMPANYFRC2026-04-10
307073878129433M™ Attest™3M COMPANYFRC2026-04-10
307073878129503M™ Attest™3M COMPANYFRC2026-04-10
07798375773607BIOTRACE™TERRAGENE S.A.FRC2026-03-10
10705037071319ULTRA GI™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FRC2025-12-15
07798164670070Bionova®TERRAGENE S.A.FRC2025-10-16
07798164670209Bionova®TERRAGENE S.A.FRC2025-10-16
07798164673545Bionova®TERRAGENE S.A.FRC2025-10-16
07798375773539ProEdgeTERRAGENE S.A.FRC2025-10-16
10686864061257AssureCheck™TERRAGENE S.A.FRC2025-10-16
07798375773034BIOTRACE™TERRAGENE S.A.FRC2025-03-06
M9850141001Spore StripMESA LABORATORIES, INC.FRC2025-01-15
M9850161001Spore Strip - EO/Dry HeatMESA LABORATORIES, INC.FRC2025-01-15
M9850341001Spore StripMESA LABORATORIES, INC.FRC2025-01-15
M9850351001Spore Strip Steam & ChemiclaveMESA LABORATORIES, INC.FRC2025-01-15
M9850361001Spore Strip Steam & ChemiclaveMESA LABORATORIES, INC.FRC2025-01-15
M985051000C1Dual Spore Strips - ControlMESA LABORATORIES, INC.FRC2025-01-15
M985051000T1Dual Spore Strips - TestMESA LABORATORIES, INC.FRC2025-01-15
M985055100T1Dual Spore Strip - TestMESA LABORATORIES, INC.FRC2025-01-15
M985HFY5201017950 HealthFirst Mail-In Spore Testing Service, 52 TestsMESA LABORATORIES, INC.FRC2024-12-18
07798375772624BIOTRACE™TERRAGENE S.A.FRC2024-11-12
07798375772945BIOTRACE™TERRAGENE S.A.FRC2024-11-12
07798375772983BIOTRACE™TERRAGENE S.A.FRC2024-11-12
10686864060892Medicom® AssureCheck™AMD Medicom IncFRC2024-10-14