FDA.reportPublic FDA data

PENTAX

Primary DI
04961333084500
Brand
PENTAX
Company
HOYA CORPORATION
Model
OF-B141
Device description
Suction Channel Selector OF-B141
Published
2023-07-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FDSGastroscope And Accessories, Flexible/Rigid
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDSGastroscope And Accessories, Flexible/RigidGastroenterology, Urology2
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041397000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041397000EG-3830UTPentax Precision Instrument Corp.2004-06-09ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333084500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333084500049613330845004961333084500

GMDN Terms#

Term, Definition table
TermDefinition
Device control handling knobA hand-held manual (non-electronic) attachment in the form of a large, easy-grip knob intended to be attached to the manual control of a medical device (e.g., endoscope) to assist a healthcare professional to operate the device. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""High-level Disinfectant"", ""Ethylene Oxide""]"
High-level Disinfectant;Ethylene Oxide

Regulatory Flags#

DUNS number
691519705
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04961333255528PENTAX MedicalOE-B92026-08-25
04961333256181PENTAXOF-B1902026-08-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701104600420T-LiteSONOSCANNERITX2026-08-25
04580826920035PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920066PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920141PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920271PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920325PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920660PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920769PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920806PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826921230PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826921278PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826921353PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826921865PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826921940PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826921957PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826925672PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826925702PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826925832PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926068PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926075PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926082PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926099PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926136PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926143PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926167PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926198PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926204PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926235PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25
04580826926242PENTAX MedicalPENTAX MEDICAL CORPORATIONFDS2026-08-25