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 large intestine. This device may be used on adults, adolescents and children requiring endoscopic examination and as deemed appropriate by trained medical professionals.
Catalog Number
-
Brand Name
FUJIFILM
Version/Model Number
EC-530LS2
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
FDF
Product Code Name
Colonoscope and accessories, flexible/rigid
Public Device Record Key
dcbc8a34-028b-4f99-82cc-4dc69081a92c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 14, 2016
Package DI Number
14547410323860
Quantity per Package
1
Contains DI Package
04547410323863
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 |