FDA.reportPublic FDA data

PENTAX

Primary DI
14961333079343
Brand
PENTAX
Company
HOYA CORPORATION
Model
OF-B173
Device description
Rubber Inlet Seal OF-B173
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
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FDSGastroscope And Accessories, Flexible/Rigid

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14961333079343PrimaryGS10
04961333079346Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1496133307934314961333079343
04961333079346049613330793464961333079346

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
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
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
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
04961333248315PENTAXEG29-i102020-12-14
04961333248483PENTAX MedicalEG29-i10c2020-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664925645NAHangzhou AGS MedTech Co., Ltd.FDS2026-06-18
06959664925676NAHangzhou AGS MedTech Co., Ltd.FDS2026-06-18
06959664925584NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664925614NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664925959NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664925980NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926017NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926048NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926314NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926345NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926376NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926406NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926673NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926703NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926734NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926765NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927038NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927069NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927090NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927120NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927403NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927434NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927465NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927496NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664928943NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664928974NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664929001NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664929032NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664929070NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664929100NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15