Duns Number:713565195
Device Description: This device is intended for the visualization of the lower digestive tract, specifically f This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.
Catalog Number
-
Brand Name
FUJIFILM
Version/Model Number
ES-530WE
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
FAM
Product Code Name
sigmoidoscope and accessories, flexible/rigid
Public Device Record Key
9044ee42-65f6-41f3-aff6-2cd232a533f0
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 14, 2016
Package DI Number
14547410333296
Quantity per Package
1
Contains DI Package
04547410333299
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 |