FDA.reportPublic FDA data

ENDOZIME PREMIUM w/APA (60 Liter Drum)

Primary DI
00810929015326
Brand
ENDOZIME PREMIUM w/APA (60 Liter Drum)
Company
Ruhof Corporation
Model
34526-39
Device description
Enzymatic detergents used to clean medical instruments.
Published
2025-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
00810929015326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810929015326008109290153268109290153260810929015326

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature40 Degrees Fahrenheit130 Degrees Fahrenheit
Storage Environment Temperature40 Degrees Fahrenheit130 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
082779828
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
false
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
10810929045627ENDOZIME BIO-CLEAN NP(4 Liter RB38)34525-292025-09-22
00810929011410ENDOZIME INSTRUSPONGE 4mm (FLEXIBLE) 345ESS4F2025-07-11
00810929011281ENDOZIME INSTRUSPONGE 1mm (RIGID)345ESS1R2025-07-10
00810929011298ENDOZIME INSTRUSPONGE 1.5mm (RIGID) 345ESS1.5R2025-07-10
00810929011519ENDOZIME INSTRUSPONGE 1.75mm (RIGID) 345ESS2R2025-07-10
00810929011311ENDOZIME INSTRUSPONGE 3mm (RIGID) 345ESS3R2025-07-10
00810929011526ENDOZIME INSTRUSPONGE 5mm (RIGID) 345ESS5R2025-07-10
00810929011335ENDOZIME INSTRUSPONGE 7mm (RIGID) 345ESS7R2025-07-10
00810929011342ENDOZIME INSTRUSPONGE 10mm (RIGID) 345ESS10R2025-07-10
00810929011359ENDOZIME INSTRUSPONGE 12mm (RIGID) 345ESS12R2025-07-10
00810929011366ENDOZIME INSTRUSPONGE 14mm (RIGID) 345ESS14R2025-07-10
00810929011373ENDOZIME INSTRUSPONGE 1mm (FLEXIBLE) 345ESS1F2025-07-10
00810929011397ENDOZIME INSTRUSPONGE 2mm (FLEXIBLE) 345ESS2F2025-07-10
00810929011403ENDOZIME INSTRUSPONGE 3mm (FLEXIBLE) 345ESS3F2025-07-10
00810929011427ENDOZIME INSTRUSPONGE 5mm (FLEXIBLE) 345ESS5F2025-07-10
00810929017238SCOPEVALET DUAL END VALVE BRUSH345VB2025-07-10
00810929043817Double Head Stubby Valve BrushSB1802025-07-10
00810929043855Push Thru 60 PackSVPT602025-07-10
00810929011380ENDOZIME INSTRUSPONGE 1.5mm (FLEXIBLE) 345ESS1.5F2025-07-07
00810929016804SCOPEVALET ENDO BRUSH (2-4mm)345EBS2025-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848956021263SanizymeHEALTHMARK INDUSTRIES CO., INC.FLG2026-05-22
00848956021287SanizymeHEALTHMARK INDUSTRIES CO., INC.FLG2026-05-22
00848956021294SanizymeHEALTHMARK INDUSTRIES CO., INC.FLG2026-05-22
00848956021317SanizymeHEALTHMARK INDUSTRIES CO., INC.FLG2026-05-22
00889813067970Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFLG2026-03-22
00889813067987Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFLG2026-03-22
07640397422042StatClean Ultrasonic CleanerDent4You AGFLG2026-03-11
07340153711815Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153711822Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153711839Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153711846Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153715837Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153715844Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153715851Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153715882Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153715899Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153715905Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153715912Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153715929Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153715943Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153715974Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153716001Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153716018Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153716025Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153716032Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153716049Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153716056Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153716063Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153716070Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25
07340153716087Ultra Clean SystemsGetinge Disinfection ABFLG2026-02-25