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
04961333225262DEFINAEPK-3000-US2018-04-16
04961333230594N/A9122D2017-04-06
04961333232154VIDEO BRONCHOSCOPEEB-1170K2017-04-06
04961333232161VIDEO BRONCHOSCOPEEB-1570K2017-04-06
04961333232178VIDEO BRONCHOSCOPEEB-1575K2017-04-06
04961333232185VIDEO BRONCHOSCOPEEB-1970K2017-04-06
04961333232192VIDEO BRONCHOSCOPEEB-1970TK2017-04-06
04961333232208ULTRASOUND BRONCHOSCOPEEB-1970UK2017-04-06
04961333232215VIDEO BRONCHOSCOPEEB-1975K2017-04-06
04961333232222VIDEO BRONCHOSCOPEEB-1990I2017-04-06
04961333232239VIDEO COLONOSCOPEEC-2990LI2017-04-06
04961333232253VIDEO COLONOSCOPEEC-3490LI2017-04-06
04961333232260VIDEO COLONOSCOPEEC-3490LK2017-04-06
04961333232277VIDEO COLONOSCOPEEC-3490TLI2017-04-06
04961333232284VIDEO COLONOSCOPEEC34-I10L2017-04-06
04961333232345VIDEO COLONOSCOPEEC-3890LI2017-04-06
04961333232352VIDEO COLONOSCOPEEC-3890LK2017-04-06
04961333232369VIDEO COLONOSCOPEEC-3890LZI2017-04-06
04961333232376VIDEO COLONOSCOPEEC-3890TLK2017-04-06
04961333232383VIDEO COLONOSCOPEEC38-I10L2017-04-06

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