FDA.reportPublic FDA data

Monolith InstruZyme conc.

Primary DI
04064896000267
Brand
Monolith InstruZyme conc.
Company
PRISMAN INC.
Model
M205
Published
2022-01-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04064896000267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04064896000267040648960002674064896000267

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117569946
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04064896000557PWR Classic Powder MintAP-CM2024-10-24
04064896000595PWR Perio Powder MintAP-PM2024-10-24
04064896000618PWR Perio Powder NeutralAP-PN2024-10-24
04064896000571PWR Classic Powder NeutralAP-CN2024-10-24
04064896000014Air SupraUS-FRESH2024-07-28
04064896000038Air SupremeUS-PLUS2024-07-28
04064896000106"Monolith Prophy Paste Xtra COARSE ""Spearmint"" Tube"M5052021-10-10
04064896000113"Monolith Prophy Paste MEDIUM ""Spearmint"" Cup"M5042021-10-10
04064896000120"Monolith Prophy Paste SENSO ""BerryLime"" Tube"M5072021-10-10
04064896000137"Monolith Prophy Paste Xtra COARSE ""Spearmint"" Cup"M5062021-10-10
04064896000151"Monolith Prophy Paste SENSO ""Spearmint"" Tube"M5012021-10-10
04064896000168"Monolith Prophy Paste MEDIUM ""Spearmint"" Tube"M5032021-10-10
04064896000175"Monolith Prophy Paste SENSO ""Spearmint"" Cup"M5022021-10-10
04064896000366"Monolith Prophy Paste SENSO ""BerryLime"" Cup"M5082021-10-10
04064896000373"Monolith Prophy Paste MEDIUM ""BerryLime"" Tube"M5092021-10-10
04064896000380"Monolith Prophy Paste MEDIUM ""BerryLime"" Cup"M5102021-10-10
04064896000397"Monolith Prophy Paste Xtra COARSE ""BerryLime"" Tube"M5112021-10-10
04064896000403"Monolith Prophy Paste Xtra COARSE ""BerryLime"" Cup"M5122021-10-10
04064896000410Monolith Prophy Paste ZIRCOM5132021-10-10
04064896000441"Monolith Prophy Powder Genie Smile TOP ""Spearmint"""M5142021-10-10

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
H816PRR128Spec Clean Rinse AgentMicroCare, LLCFLG2025-10-22
H816PVAC128Spec Clean Evacuation System CleanerMicroCare, LLCFLG2025-10-22