Duns Number:713565195
Device Description: The Fujifilm Double Balloon Endoscopes are intended for the visualization of the upper and The Fujifilm Double Balloon Endoscopes are intended for the visualization of the upper and lower digestive tracts. Specifically, for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine, large intestine, and rectum.
Catalog Number
-
Brand Name
FUJIFILM
Version/Model Number
EN-580T
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FDA
Product Code Name
Enteroscope and accessories
Public Device Record Key
12741d0a-5b42-47f0-a406-e80372812088
Public Version Date
February 21, 2019
Public Version Number
3
DI Record Publish Date
December 14, 2016
Package DI Number
14547410330240
Quantity per Package
1
Contains DI Package
04547410330243
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 |