FDA.reportPublic FDA data

Olympus Endoscopy Kit

Primary DI
10810929045702
Brand
Olympus Endoscopy Kit
Company
Ruhof Corporation
Model
345CKETM
Device description
Underpad – Improved durability ECO-Bedside Kit Luer Tip Syringe Suction Tubing – 12 foot Gauze Pads – softer Biohazard Label Case (12kits)
Published
2026-08-07
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

Contact Domains#

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
10810929045702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081092904570210810929045702

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.

Contacts#

Phone, Email table
PhoneEmail
8883647004customerservice@aspensurgical.com

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
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
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
00810929045613ENDOZIME BIO-CLEAN NP(4 Liter RB38)34525-302025-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810929045668Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
00810929045675Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
00810929045682Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
00810929045699Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
00810929045705Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
00810929045712Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
00810929045729Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
00810929045736Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
01081092904567Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045665Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045689Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045696Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045719Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045726Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045733Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
006664161214969000 Series Disposable Channel Cleaning BrushPrimed Instruments IncMNL2026-07-08
006664161220119000 Series Disposable Channel Cleaning BrushPrimed Instruments IncMNL2026-07-08
00846338007164EndiscopeELLIQUENCE, LLCMNL2026-06-02
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
06936603225691Disposable Cleaning BrushYangzhou Fartley Medical Instrument Technology Co., LtdMNL2024-01-30