FDA.reportPublic FDA data

Fuse®

Primary DI
00840253109828
Brand
Fuse®
Company
ENDOCHOICE, INC.
Model
FSG250-H7642
Device description
Gastroscope
Published
2016-09-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
00840253109828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840253109828008402531098288402531098280840253109828

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

Contacts#

Phone, Email table
PhoneEmail
888-632-3636customercare@endochoice.com

Regulatory Flags#

DUNS number
014154279
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840253110067Seal®SBC-5802017-11-06
00840253101068Seal®SBC-4602016-09-08
00816849010113Seal®SBC-3652016-09-08
00816849010120Seal®SBC-3662016-09-08
00840253103932FuseBoxFSP-100-ARFSP-100-AR2017-08-11
00840253104267FuseBoxLS-FSP-100LS-FSP-1002017-08-11
00840253104274FuseBoxLS-FSP-100-ARLS-FSP-100-AR2017-08-11
00840253109521Fuse®FDEMO-F75232016-09-08
00840253109538Fuse®FDEMO-F75242016-09-08
00840253109545Fuse®FDEMO-F75252016-09-08
00840253109552Fuse®FSC330-F75262016-09-08
00840253109576Fuse® FSC330-F7528FSC330-F75282016-09-08
00840253109583Fuse®FSC330-G75292016-09-08
00840253109590Fuse® FSC330-G75302016-09-08
00840253109606Fuse® FSC330-G75312016-09-08
00840253109811Fuse®FSG250-H76412016-09-08
00840253109835Fuse®FSC330-F75232016-09-08
00840253109842Fuse®FSC330-F75242016-09-08
00840253109859Fuse®FSC330-F75252016-09-08
00840253109866Fuse®FSC330-G75202016-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664925645NAHangzhou AGS MedTech Co., Ltd.FDS2026-06-18
06959664925676NAHangzhou AGS MedTech Co., Ltd.FDS2026-06-18
06959664925584NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664925614NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664925959NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664925980NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926017NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926048NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926314NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926345NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926376NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926406NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926673NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926703NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926734NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664926765NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927038NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927069NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927090NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927120NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927403NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927434NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927465NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664927496NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664928943NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664928974NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664929001NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664929032NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664929070NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15
06959664929100NAHangzhou AGS MedTech Co., Ltd.FDS2026-04-15