FDA.reportPublic FDA data

Sanizyme 2.5-Gallon

Primary DI
20816634020079
Brand
Sanizyme 2.5-Gallon
Company
Ultra Clean Systems, Inc.
Model
92-0000
Device description
Sanizyme 2.5-Gallon, 2 pack
Published
2025-03-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
10816634020072PackageGS116In Commercial Distribution
20816634020079PackageGS12In Commercial Distribution
00816634020075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081663402007210816634020072
2081663402007920816634020079
00816634020075008166340200758166340200750816634020075

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
010043227
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816634020389Xi AdapterXi Adapter2025-07-09
00816634020419Xi Adapter R2Xi Adapter R22025-07-09
00816634020426D5 AdapterD5 Adapter2025-07-09
00816634020396Xi AdapterXi Adapter2025-07-09
00816634020464Xi Adapter R2Xi Adapter R22025-07-09
00816634020488D5 AdapterD5 Adapter2025-07-09
00816634020440SP Adapter SP Adapter 2025-07-09
108166340202631101 - Xi RACS tray with adapters (6)11012025-01-13
008166340201361100 - Lumen Tray with Accessory Kit11002025-01-13
008166340201431150 - Lumen Tray with Accessory Kit11502025-01-13
008166340201501101 - Lumen Tray with Accessory Kit11012025-01-13
008166340201811100 - Lumen Tray Only11002025-01-13
008166340201981101 - Lumen tray only11012025-01-13
008166340202041150 - Lumen tray only11502025-01-13
00816634020211Triton series - Lumen tray only36/722025-01-13
00816634020228Triton series - Lumen tray with an accessory kit36/722025-01-13
008166340202351101 RACS tray with S & SI adapters (8 pcs. - blue)11012025-01-13
008166340202731101 - SP Tray with adapters11012025-01-13
008166340202801150/1522 - RACS tray with S & SI adapters (blue)1150/15222025-01-13
00816634020327Triton RACS tray S & Si with adapters (10)36/722025-01-13

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