FDA.reportPublic FDA data

PENTAX Medical

Primary DI
04580826926044
Brand
PENTAX Medical
Company
PENTAX MEDICAL CORPORATION
Model
CS5522A
Device description
PENTAX Medical PROfILE Single-Use Cleaning Brush
Published
2026-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
04580826926044PrimaryGS10
84580826926040Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580826926044045808269260444580826926044
8458082692604084580826926040

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/endoscope cleaning utensil, single-useA non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a single-use device.

Regulatory Flags#

DUNS number
691559848
Device count
10
DM exempt
true
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
false
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
04580826920035PENTAX MedicalEG29-i20c2026-08-25
04580826920066PENTAX MedicalEG27-i20c2026-08-25
04580826920141PENTAX MedicalEC38-i20cL2026-08-25
04580826920271PENTAX MedicalEC34-i20cL2026-08-25
04580826920295PENTAX MedicalEC38-i20cWL2026-08-25
04580826920325PENTAX MedicalEG29-i10c2026-08-25
04580826920394PENTAX MedicalEC38-i10cL2026-08-25
04580826920462PENTAX MedicalEC34-i10cL2026-08-25
04580826920653PENTAX MedicalEE17-J102026-08-25
04580826920660PENTAX MedicalEG17-J102026-08-25
04580826920684PENTAX MedicalEB19-J10U2026-08-25
04580826920721PENTAX MedicalEG38-J10UT2026-08-25
04580826920769PENTAX MedicalEG36-J10UR2026-08-25
04580826920806PENTAX MedicalEG34-J10U2026-08-25
04580826920899PENTAX MedicalEB19-J102026-08-25
04580826920929PENTAX MedicalEB15-J102026-08-25
04580826920950PENTAX MedicalEB11-J102026-08-25
04580826921001PENTAX MedicalVNL11-J102026-08-25
04580826921056PENTAX MedicalVNL11-J102026-08-25
04580826921063PENTAX MedicalVNL8-J102026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826926051PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926341PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926471PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926488PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926648PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926679PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926686PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826926761PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826927232PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826928369PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826928376PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826931789PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826931796PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
04580826931802PENTAX MedicalPENTAX MEDICAL CORPORATIONMNL2026-08-25
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
10810929045702Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045719Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045726Olympus Endoscopy KitRuhof CorporationMNL2026-08-07
10810929045733Olympus Endoscopy KitRuhof CorporationMNL2026-08-07