FDA.reportPublic FDA data

Endoch

Primary DI
GS5007
Brand
Endoch
Company
Endoch Inc
Model
GS-500L
Catalog number
GS-500L
Device description
Video Gastroscope
Published
2019-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
GS5007PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video gastroscopeAn endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus and the stomach. It is inserted into the body through the mouth during gastroscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end and of the endoscope and the images showing on a monitor. This device is commonly used in the evaluation or treatment of unusual abdominal pain, bleeding, cancer, chronic heartburn, polyps, gastritis, ulcers, or hiatal hernia. Physicians may also use the device to obtain biopsies or perform other procedures. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
241382683
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
GS3300EndochGS-330GS-3302019-06-01
GS3309EndochGS-330BGS-330B2019-06-01
GS4300EndochGS-430GS-4302019-06-01
GS4307EndochGS-430LGS-430L2019-06-01
GS5000EndochGS-500GS-5002019-06-01
B747EAI0496EndochEAI-0496EAI-04962019-10-01
B747EAI0502EndochEAI-0502EAI-05022019-10-01
B747EAI0503EndochEAI-0503EAI-05032019-10-01
B747EAI0535EndochEAI-0535EAI-05352019-10-01
B747EAI0628EndochEAI-0628EAI-06282019-10-01
B747EAI0784EndochEAI-0784EAI-07842019-10-01
B747EAI0785EndochEAI-0785EAI-07852019-10-01
B747EAI0787EndochEAI-0787EAI-07872019-10-01
B747EAI0788EndochEAI-0788EAI-07882019-10-01
B747EAI0793Endoch EAI-0793EAI-07932019-10-01
DGF23181EndochDGF-2318ADGF-2318A2019-06-03
DGF231858EndochDGF-2318RTDGF-2318RT2019-06-03
DGF23189EndochDGF-2318GDGF-2318G2019-06-03
DGF23231EndochDGF-2323ADGF-2323A2019-06-03
DGF232358EndochDGF-2323RTDGF-2323RT2019-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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