FDA.reportPublic FDA data

Spec Clean Rinse Agent

Primary DI
H816PRR128
Brand
Spec Clean Rinse Agent
Company
MicroCare, LLC
Model
PRR128
Catalog number
PRR128
Device description
Rinse Agent
Published
2025-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FLGCleaner, Ultrasonic, Medical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLGCleaner, Ultrasonic, Medical InstrumentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
PRR128PackageHIBCC4In Commercial Distribution
H816PRR128PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical device cleaning agentA substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental and/or surgical instruments/devices for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds prior to disinfection or sterilization; it is not intended for in vitro diagnostic device use. It includes a detergent and may be added, as manufacturer specified, to water for cleaning and/or be applied directly to soiled devices immediately after their use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
118518186
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H816MPM10161ProView PlusPM1016PM1016-12022-10-26
H816MPM13181ProView PlusPM1318PM1318-12022-10-26
H816MPM24401ProView PlusPM2440PM2440-12022-10-26
H816MPM27901ProView PlusPM2790PM2790-12022-10-26
H816MPM35541ProView PlusPM3554PM3554-12022-10-26
H816MPM35901ProView PlusPM3590PM3590-12022-10-26
H816MPM54101ProView PlusPM5410PM5410-12022-10-26
H816GEL121Spec Clean Pre Treatment GelGEL12GEL122025-10-23
H816OP1281OptizymeOP128OP1282025-10-23
H816PSC050Spec Clean Ready to Use DisinfectantPSC050PSC0502025-10-23
H816PSC128Spec Clean Ready to Use DisinfectantPSC128PSC1282025-10-23
H816PSC240Spec Clean Ready to Use DisinfectantPSC240PSC2402025-10-23
H816PSC6032Spec Clean Concentrated DisinfectantPSC6032PSC60322025-10-23
H816EZ128Spec Clean Single Enzymatic DetergentEZ128EZ1282025-10-22
H816EZTAB641Spec Clean Enzymatic TabletsEZTAB64EZTAB642025-10-22
H816PCNF128Spec Clean Instrument Detergent AlkalinePCNF128PCNF1282025-10-22
H816PLC128Spec Clean Concentrated Instrument LubricantPLC128PLC1282025-10-22
H816PLR32Spec Clean Instrument LubricantPLR32PLR322025-10-22
H816PREZ128Spec Clean Dual Enzymatic DetergentPREZ128PREZ1282025-10-22
H816PREZ275Spec Clean Dual Enzymatic DetergentPREZ275PREZ2752025-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10724995218864PRE-KLENZSTERIS CORPORATIONFLG2026-03-25
50724995218848PRE-KLENZSTERIS CORPORATIONFLG2026-03-25
50724995218855PRE-KLENZSTERIS CORPORATIONFLG2026-03-25
00724995231057ProlysticaSTERIS CORPORATIONFLG2026-01-14
00724995231064ProlysticaSTERIS CORPORATIONFLG2026-01-14
00724995231071ProlysticaSTERIS CORPORATIONFLG2026-01-14
10705037018062ENZOL™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FLG2025-12-16
10705037018130CIDEZYME™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FLG2025-12-16
10705037018154CIDEZYME™ XTRAADVANCED STERILIZATION PRODUCTS SERVICES INC.FLG2025-12-16
10705037018161CIDEZYME™ADVANCED STERILIZATION PRODUCTS SERVICES INC.FLG2025-12-16
00724995229559PRE-KLENZSTERIS CORPORATIONFLG2025-12-16
D661UC300230CE1BioSonicCOLTENE/WHALEDENT INCFLG2025-11-21
D661UC50DB230CE1BioSonicCOLTENE/WHALEDENT INCFLG2025-11-21
D661UC50DB230UK1BioSonicCOLTENE/WHALEDENT INCFLG2025-11-21
H816GEL121Spec Clean Pre Treatment GelMicroCare, LLCFLG2025-10-23
H816OP1281OptizymeMicroCare, LLCFLG2025-10-23
H816EZ128Spec Clean Single Enzymatic DetergentMicroCare, LLCFLG2025-10-22
H816EZTAB641Spec Clean Enzymatic TabletsMicroCare, LLCFLG2025-10-22
H816PCNF128Spec Clean Instrument Detergent AlkalineMicroCare, LLCFLG2025-10-22
H816PLC128Spec Clean Concentrated Instrument LubricantMicroCare, LLCFLG2025-10-22
H816PLR32Spec Clean Instrument LubricantMicroCare, LLCFLG2025-10-22
H816PREZ128Spec Clean Dual Enzymatic DetergentMicroCare, LLCFLG2025-10-22
H816PREZ275Spec Clean Dual Enzymatic DetergentMicroCare, LLCFLG2025-10-22
H816PREZAW050Spec Clean Quad Enzymatic DetergentMicroCare, LLCFLG2025-10-22
H816PREZAW128Spec Clean Quad Enzymatic DetergentMicroCare, LLCFLG2025-10-22
H816PREZF128Spec Clean Pre Treatment Foam SprayMicroCare, LLCFLG2025-10-22
H816PREZF240Spec Clean Pre Treatment Foam SprayMicroCare, LLCFLG2025-10-22
H816PRR050Spec Clean Rinse AgentMicroCare, LLCFLG2025-10-22
H816PVAC128Spec Clean Evacuation System CleanerMicroCare, LLCFLG2025-10-22
H816PVAC275Spec Clean Evacuation System CleanerMicroCare, LLCFLG2025-10-22