FDA.reportPublic FDA data

PENTAX

Primary DI
04961333256181
Brand
PENTAX
Company
HOYA CORPORATION
Model
OF-B190
Device description
Rubber Inlet Seal OF-B190
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
EOBNasopharyngoscope (Flexible Or Rigid)
PEAEndoscope, Accessories, Image Post-Processing For Color Enhancement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2
PEAEndoscope, Accessories, Image Post-Processing For Color EnhancementGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333256181PrimaryGS10
84961333256187Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333256181049613332561814961333256181
8496133325618784961333256187

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope working-channel valve, reusableA device in the form of a small attachment intended to be fitted to the working channel (including biopsy port) of an endoscope to enable access for, and/or exchange of, an endoscopic device while minimizing leakage of liquids and gasses during an endoscopic procedure. Also referred to as a seal, it may be Luer formatted and include features to allow for simultaneous irrigation/biopsy or suction via the working channel. This is a reusable device.

Sterilization Methods#

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

Regulatory Flags#

DUNS number
691519705
Device count
10
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
true
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
04961333255528PENTAX MedicalOE-B92026-08-25
14961333079343PENTAXOF-B1732023-07-31
14961333085535PENTAXOE-A412023-07-31
14961333232960PENTAX MedicalOE-A622023-07-31
04961333084753PENTAXOF-B802023-07-31
04961333225569PENTAX MedicalEB19-J10U2020-07-17
04961333239825VIVIDEOCP-10002024-02-07
04961333244744DEFINAEPK-30002020-07-17
04961333245888PENTAX MedicalEG34-i102020-07-17
04961333246632PENTAX MedicalED32-i102022-02-02
04961333246779PENTAXEC-3890Li2025-04-04
04961333246830PENTAXEC38-i10L2025-04-04
04961333246847PENTAXEG-2990i2025-04-04
04961333246939PENTAXEG29-i102025-04-04
04961333248056PENTAX MedicalVNL11-J102022-02-02
04961333248063PENTAX MedicalVNL8-J102022-02-02
04961333248070PENTAX MedicalVNL15-J102022-02-02
04961333248148PENTAXEC-3890Li2020-12-14
04961333248179PENTAXEG-2990i2020-12-14
04961333248209PENTAXEC38-i10L2020-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826920035PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826920141PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826921001PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921056PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921063PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921070PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921117PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921148PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921209PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826921209PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826922473PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826922497PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826925153OPTIVISTAPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925245DEFINAPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925450IMAGINAPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925672PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925696PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925702PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925719PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925719PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826925726PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925726PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826925832PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925849PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925856PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925894PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925900PENTAX MedicalPENTAX MEDICAL CORPORATIONPEA2026-08-25
04580826925948VIVIDEOPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826925979PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926006VIVIDEOPENTAX MEDICAL CORPORATIONEOB2026-08-25