FDA.reportPublic FDA data

ENDOZIME INSTRUSPONGE 4mm (FLEXIBLE)

Primary DI
00810929010147
Brand
ENDOZIME INSTRUSPONGE 4mm (FLEXIBLE)
Company
Ruhof Corporation
Model
345ESS4F
Device description
brushes to clean medical instrumnets
Published
2025-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
00810929011410PackageGS1100In Commercial Distribution
00810929010147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810929011410008109290114108109290114100810929011410
00810929010147008109290101478109290101470810929010147

GMDN Terms#

Term, Definition table
TermDefinition
Semiconductor-type radiation survey meterA portable or permanently installed radiation detection and spectroscopy instrument, that detects neutron, beta and alpha particles by the production of electron-hole pairs along the path of the charged particle in a semiconductor. It typically consists of a semiconductor diode, using an ohmic contact (a non rectifying electrode) and a detection circuit to measure the resulting current, electronics, and read out sub-system. The semiconductor acts like a solid ionization chamber. It has fast timing characteristics but is susceptible to performance degradation from radiation induced damage and may measure doses during radiation therapy treatments.

Storage And Handling#

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

Regulatory Flags#

DUNS number
082779828
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
00810929045668Olympus Endoscopy Kit345CKETI2026-08-07
00810929045675Olympus Endoscopy Kit345CKETJ2026-08-07
00810929045682Olympus Endoscopy Kit345CKETK2026-08-07
00810929045699Olympus Endoscopy Kit345CKETIL2026-08-07
00810929045705Olympus Endoscopy Kit345CKETM2026-08-07
00810929045712Olympus Endoscopy Kit345CKETN2026-08-07
00810929045729Olympus Endoscopy Kit345CKETO2026-08-07
00810929045736Olympus Endoscopy Kit345CKETP2026-08-07
01081092904567Olympus Endoscopy Kit345CKETJ2026-08-07
10810929045665Olympus Endoscopy Kit345CKETI2026-08-07
10810929045689Olympus Endoscopy Kit345CKETK2026-08-07
10810929045696Olympus Endoscopy Kit345CKETIL2026-08-07
10810929045702Olympus Endoscopy Kit345CKETM2026-08-07
10810929045719Olympus Endoscopy Kit345CKETN2026-08-07
10810929045726Olympus Endoscopy Kit345CKETO2026-08-07
10810929045733Olympus Endoscopy Kit345CKETP2026-08-07
00810929045637Liquizime XP (4 Liter RB53)54323-312025-10-17
00810929045644Endozime Premium XP (4 Liter RB53)54324-312025-10-17
00810929045620ENDOZIME BIO-CLEAN NP(4 Liter RB38)34525-292025-09-22
10810929045627ENDOZIME BIO-CLEAN NP(4 Liter RB38)34525-292025-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456222515JMUJMU DENTAL, INCFLG2026-07-20
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