FDA.reportPublic FDA data

PENTAX Medical

Primary DI
04580826928628
Brand
PENTAX Medical
Company
PENTAX MEDICAL CORPORATION
Model
OF-B191
Device description
O-Ring Set For OF-B172 OF-B191
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
false

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
ODGEndoscopic Ultrasound System, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
ODGEndoscopic Ultrasound System, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04580826928628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580826928628045808269286284580826928628

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope air/water valve, reusableA device intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases [i.e., air, carbon dioxide (CO2)] and/or water whilst preventing backflow. It is in the form of an attachable valve with one or more settings such as closed, insufflation (allowing air/gas in), and irrigation/rinse (allowing water in). This is a reusable device intended to be reprocessed prior to use.

Sterilization Methods#

Method table
Method
Ethylene Oxide
High-level Disinfectant
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
691559848
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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
03701104600420T-LiteSONOSCANNERITX2026-08-25
04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920769PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826920769PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920806PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826920806PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926365PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926396PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926396PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926501PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926501PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926518PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926518PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926532PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926532PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926556PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926556PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926600PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926723PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826927010PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826927881PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826927881PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928291PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928291PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928307PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928444PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928468PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928468PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928567PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25