Duns Number:713565195
Device Description: FUJIFILM Endoscope Model EG-740N is intended for the visualization of the upper digestive FUJIFILM Endoscope Model EG-740N is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. This product can be inserted orally or nasally.
Catalog Number
-
Brand Name
FUJIFILM
Version/Model Number
EG-740N
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FDS
Product Code Name
Gastroscope And Accessories, Flexible/Rigid
Public Device Record Key
74cbe247-4a37-4d69-8593-6541834c7038
Public Version Date
August 16, 2019
Public Version Number
1
DI Record Publish Date
August 08, 2019
Package DI Number
14547410377245
Quantity per Package
1
Contains DI Package
04547410377248
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 43 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 324 |
| 3 | A medical device with high risk that requires premarket approval | 1 |