FDA.reportPublic FDA data

N/A

Primary DI
04961333242047
Brand
N/A
Company
PENTAX OF AMERICA, INC.
Model
7195B
Device description
PORTABLE RECORDABLE ENDSCOPY S
Published
2018-03-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FWGCamera, Television, Endoscopic, With Audio

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWGCamera, Television, Endoscopic, With AudioGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333242047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333242047049613332420474961333242047

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope video cameraAn electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.

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
68051887046715THD Procto Software SystemTHD SPAFWG2025-02-20
04250365190717ATMOSATMOS MedizinTechnik GmbH & Co. KGFWG2024-11-27
68051887043295THD Procto Software SystemTHD SPAFWG2023-12-14
68051887043301THD Procto Software SystemTHD SPAFWG2023-12-14
68051887043318THD Procto Software SystemTHD SPAFWG2023-12-14
68051887043325THD Procto Software SystemTHD SPAFWG2023-12-14
18033737712341THD Procto Software SystemTHD SPAFWG2022-10-07
58051887042642THD Procto Software SystemTHD SPAFWG2022-10-07
08033737713037THD Procto Software SystemTHD SPAFWG2021-07-19
18033737712389THD Procto Software SystemTHD SPAFWG2021-07-19
00815440022228SenhanceAsensus Surgical, Inc.FWG2021-02-19
04055207057469ENDOCAMRichard Wolf GmbHFWG2017-07-21
04961333231621n/aPENTAX OF AMERICA, INC.FWG2017-04-06
04055207055007NARichard Wolf GmbHFWG2016-09-23
04055207055014NARichard Wolf GmbHFWG2016-09-23