FDA.reportPublic FDA data

PENTAX

Primary DI
04961333078004
Brand
PENTAX
Company
HOYA CORPORATION
Model
AP-PV1
Device description
Adapter for P.Fiberscope to PVA-1010 AP-PV1
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
FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)Gastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333078004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333078004049613330780044961333078004

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope camera adaptorAn optical device designed to connect a camera (moving- or still-image) to a non-video endoscope (rigid or flexible), especially when the devices are from different manufacturers. It may be referred to as a coupler. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04961333227747PENTAXBS-LC12017-04-07
04961333228362PENTAXEG-3670URK2017-04-07
04961333228409PENTAXEG-3870UTK2017-04-07
04961333233793PENTAXEG-3270UK2018-08-10
04961333254316PENTAXEC-2990Li2024-07-26
04961333254323PENTAXEC34-i10L2024-07-26
04961333254330PENTAXEC-3890TLK2024-07-26
04961333254347PENTAXEC38-i10L2024-07-26
04961333254354PENTAXEC-3890Li2024-07-26
04961333254385PENTAXEG-2490K2024-07-26
04961333254392PENTAXEG27-i102024-07-26
04961333254408PENTAXEG-2990i2024-07-26
04961333254422PENTAXEG29-i102024-07-26
04961333254439PENTAXEG-3890TK2024-07-26
04961333255238VIVIDEOCP-10002025-12-19
04961333255306VIVIDEOVNL9-CP2025-12-19
04961333255191VIVIDEOCP-10002025-12-19
04961333255245VIVIDEOVNL9-CP2025-12-19
04961333254620PENTAX MedicalOE-B172024-12-13
04961333077731PENTAXOF-B1612023-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810004820460Light Cable, ACMI-ACMI, 1mmCLARUS MEDICAL, LLCFEM2024-12-30
00810004820463Light Cable, ACMI-ACMI, 1mmCLARUS MEDICAL, LLCFEM2024-12-30
10810004820125Light Cable, ACMI-Wolf/Dyonics, 1mmCLARUS MEDICAL, LLCFEM2024-12-23
10810004820132Light Cable, ACMI-Olympus, 1mmCLARUS MEDICAL, LLCFEM2024-12-23
10810004820149Light Cable, ACMI-Storz, 1mmCLARUS MEDICAL, LLCFEM2024-12-23
10810004820705Adapter, ACMICLARUS MEDICAL, LLCFEM2024-12-23
10810004820712Adapter, OlympusCLARUS MEDICAL, LLCFEM2024-12-23
10810004820729Adapter, StorzCLARUS MEDICAL, LLCFEM2024-12-23
10810004820736Adapter, Wolf/DyonicsCLARUS MEDICAL, LLCFEM2024-12-23
10810004820750Universal Light CableCLARUS MEDICAL, LLCFEM2024-12-23
00810004820128Light Cable, ACMI-Wolf/Dyonics, 1mmCLARUS MEDICAL, LLCFEM2024-12-23
00810004820135Light Cable, ACMI-Olympus, 1mmCLARUS MEDICAL, LLCFEM2024-12-23
00810004820142Light Cable, ACMI-Storz, 1mmCLARUS MEDICAL, LLCFEM2024-12-23
00810004820708Adapter, ACMICLARUS MEDICAL, LLCFEM2024-12-23
00810004820715Adapter, OlympusCLARUS MEDICAL, LLCFEM2024-12-23
00810004820722Adapter, StorzCLARUS MEDICAL, LLCFEM2024-12-23
00810004820739Adapter, Wolf/DyonicsCLARUS MEDICAL, LLCFEM2024-12-23
00810004820753Universal Light CableCLARUS MEDICAL, LLCFEM2024-12-23
04055207001189NARichard Wolf GmbHFEM2024-08-06
04055207025024RIWOMOBILRichard Wolf GmbHFEM2024-08-06
04051423002085TV-adapterasap endoscopic products GmbHFEM2024-07-11
04055207008928NARichard Wolf GmbHFEM2024-05-21
04055207009086NARichard Wolf GmbHFEM2024-05-21
04055207009116NARichard Wolf GmbHFEM2024-05-21
08800182600041ScopEYEMediThinQ Co., Ltd.FEM2024-02-16
08800182600195ScopEYEMediThinQ Co., Ltd.FEM2024-02-16
08800182600331ScopEYEMediThinQ Co., Ltd.FEM2024-02-16
08800182600355ScopEYEMediThinQ Co., Ltd.FEM2024-02-16
06972197480887PylonHunan Vathin Medical Instrument Co., LtdFEM2023-10-31
06972197480894TrolleyHunan Vathin Medical Instrument Co., LtdFEM2023-10-31