FDA.reportPublic FDA data

N/A

Primary DI
04961333242153
Brand
N/A
Company
PENTAX OF AMERICA, INC.
Model
9118B
Device description
5197-801 ZOOM COUPLER, 17.5MM
Published
2018-03-08
Public version status
Update
Distribution status
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
04961333242153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333242153049613332421534961333242153

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope camera adaptorA 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. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length37Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
083211284
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854924006255C2 CryoBalloon Ablation System FG-10252025-04-04
00854924006293C2 CryoBalloon Ablation SystemFG-10292025-04-04
04961333255313C2 CryoBalloonFG-10552024-09-12
04961333255320C2 CryoBalloonFG-10562024-09-12
04961333248445C2 CryoBalloon NitroclipFG-10502020-08-07
00854924006408C2 CryoBalloon EndoGripFG-10402020-07-29
04961333232550ULTRASOUND GASTROSCOPEEG-3670URK2017-04-06
04961333232567ULTRASOUND GASTROSCOPEEG-3870UTK2017-04-06
04961333233953ULTRASOUND GASTROSCOPEEG-3270UK2017-06-26
04961333231942VIDEO PROCESSOREPK-I5010-US2018-04-16
04961333232598VIDEO PROCESSOREPK-I50102017-04-06
04961333232604VIDEO PROCESSOREPK-I70102017-04-06
04961333242207N/A92026/102018-03-08
04961333242214N/A92026/252018-03-08
04961333242221N/A92026/32018-03-08
04961333242238N/A92026/502018-03-08
04961333242276N/A92052/202018-03-08
04961333242283N/A92052/62018-03-08
04961333242306N/A92092/122018-03-08
04961333242313N/A92092/252018-03-08

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