FDA.reportPublic FDA data

PENTAX Medical

Primary DI
14961333246233
Brand
PENTAX Medical
Company
HOYA CORPORATION
Model
OE-A65
Device description
Single Use, Sterile Distal End Cap with Elevator OE-A65
Published
2023-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14961333246233PrimaryGS10
04961333246236Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1496133324623314961333246233
04961333246236049613332462364961333246236

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope patient protection cap, single-useAn invasive device, typically in the form of a detachable cap, designed to cover the exposed mechanical components at the distal end of an endoscope (e.g., duodenoscope) during an endoscopic procedure to protect the patient from injury. This is a single-use device.

Regulatory Flags#

DUNS number
691519705
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04961333248315PENTAXEG29-i102020-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04953170467370SINGLE USE DISTAL COVEROLYMPUS MEDICAL SYSTEMS CORP.FDT2026-03-06
14953170467377SINGLE USE DISTAL COVEROLYMPUS MEDICAL SYSTEMS CORP.FDT2026-03-06
04961333255801INSPIRAHOYA CORPORATIONFDT2025-06-20
04961333255825INSPIRAHOYA CORPORATIONFDT2025-06-20
05707480157167Ambu® aScope™ Duodeno 2Ambu A/SFDT2025-03-29
04961333356355PENTAX MedicalHOYA CORPORATIONFDT2024-09-03
04961333356331PENTAX MedicalHOYA CORPORATIONFDT2024-09-03
05707480157143Ambu® aScope™ Duodeno 2Ambu A/SFDT2024-07-19
05707480157136Ambu® aScope™ Duodeno 2Ambu A/SFDT2024-07-19
04961333254910INSPIRAHOYA CORPORATIONFDT2023-12-01
04961333247974INSPIRAHOYA CORPORATIONFDT2023-09-16
14961333232960PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
14961333232991PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
04961333084456PENTAXHOYA CORPORATIONFDT2023-07-31
04961333084470PENTAXHOYA CORPORATIONFDT2023-07-31
04961333232963PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
04961333232994PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
04961333246236PENTAX MedicalHOYA CORPORATIONFDT2023-07-31
04953170438066Air/water valveOLYMPUS MEDICAL SYSTEMS CORP.FDT2023-04-22
04953170438349CONNECTING TUBEOLYMPUS MEDICAL SYSTEMS CORP.FDT2023-04-19
04953170441271SINGLE USE DISTAL COVEROLYMPUS MEDICAL SYSTEMS CORP.FDT2022-06-01
14953170441278SINGLE USE DISTAL COVER MAJ-2315OLYMPUS MEDICAL SYSTEMS CORP.FDT2022-06-01
04953170452024EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190VOLYMPUS MEDICAL SYSTEMS CORP.FDT2022-06-01
05707480157402aScope™ DuodenoAmbu A/SFDT2022-04-19
05707480157426aScope™ DuodenoAmbu A/SFDT2022-04-19
04961333246632PENTAX MedicalHOYA CORPORATIONFDT2022-02-02
04961333246168N/AHOYA CORPORATIONFDT2022-02-02
04953170063749EYEPIECE CAPOLYMPUS MEDICAL SYSTEMS CORP.FDT2021-12-20
04953170064012LIGHTGUIDE CAPOLYMPUS MEDICAL SYSTEMS CORP.FDT2021-12-20
03700712417512Maquet PowerLED IIMAQUET SASFDT2021-07-29