FDA.reportPublic FDA data

OLYMPUS ENDOSCOPY KIT VI

Primary DI
10810929045474
Brand
OLYMPUS ENDOSCOPY KIT VI
Company
Ruhof Corporation
Model
345CKETF
Catalog number
345CKETF
Device description
OLYMPUS ENDOSCOPY KIT VI
Published
2025-02-11
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
MNLAccessories, Cleaning Brushes, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNLAccessories, Cleaning Brushes, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810929045474PackageGS112In Commercial Distribution
00810929045477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081092904547410810929045474
00810929045477008109290454778109290454770810929045477

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopy preparation kitA collection of various devices intended to be used in the preparation of a patient and equipment for an endoscopy procedure of the gastrointestinal tract or airways. It includes devices intended to support the procedure (e.g., bite block, lubricant jelly, transport pad, bowl, cleaning devices); it does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
082779828
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
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
00810929045613ENDOZIME BIO-CLEAN NP(4 Liter RB38)34525-302025-06-17
00810929010147ENDOZIME INSTRUSPONGE 4mm (FLEXIBLE) 345ESS4F2025-07-11
00810929011410ENDOZIME INSTRUSPONGE 4mm (FLEXIBLE) 345ESS4F2025-07-11
00810929010017ENDOZIME INSTRUSPONGE 1mm (RIGID)345ESS1R2025-07-10
00810929010024ENDOZIME INSTRUSPONGE 1.5mm (RIGID) 345ESS1.5R2025-07-10
00810929010031ENDOZIME INSTRUSPONGE 1.75mm (RIGID) 345ESS2R2025-07-10
00810929010048ENDOZIME INSTRUSPONGE 3mm (RIGID) 345ESS3R2025-07-10
00810929010055ENDOZIME INSTRUSPONGE 5mm (RIGID) 345ESS5R2025-07-10
00810929010062ENDOZIME INSTRUSPONGE 7mm (RIGID) 345ESS7R2025-07-10
00810929010079ENDOZIME INSTRUSPONGE 10mm (RIGID) 345ESS10R2025-07-10
00810929010086ENDOZIME INSTRUSPONGE 12mm (RIGID) 345ESS12R2025-07-10
00810929010093ENDOZIME INSTRUSPONGE 14mm (RIGID) 345ESS14R2025-07-10
00810929010109ENDOZIME INSTRUSPONGE 1mm (FLEXIBLE) 345ESS1F2025-07-10
00810929010123ENDOZIME INSTRUSPONGE 2mm (FLEXIBLE) 345ESS2F2025-07-10
00810929010130ENDOZIME INSTRUSPONGE 3mm (FLEXIBLE) 345ESS3F2025-07-10
00810929010154ENDOZIME INSTRUSPONGE 5mm (FLEXIBLE) 345ESS5F2025-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10193489008562MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
10193489008579MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
10193489091915MEDLINEMEDLINE INDUSTRIES, INC.MNL2025-07-23
10620974004308Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-05-30
10620974004315Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-05-30
10620974004216Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004223Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004230Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004247Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004254Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
10620974004261Scope Sweeper Dual Action Endoscope Cleaning BrushesSouthmedic IncorporatedMNL2025-04-24
H816SMQEZ21Spec Clean Endoscope SpongeMicroCare, LLCMNL2023-08-30
H816QEZ21QEZCERTOL INTERNATIONAL, LLCMNL2023-06-02
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09421028490221PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-10
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09421028491211PULL THRU™ Cleaning BrushF.R.GALANTAI MANUFACTURING COMPANY LIMITEDMNL2022-10-10