Duns Number:713565195
Device Description: The Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is intended for the observation, diagno The Fujinon/Fujifilm Ultrasonic Endoscope EB-530US is intended for the observation, diagnosis and endoscopic treatment of the trachea, bronchial tree and surrounding organs using ultrasonic images. It is used with Fujinon/Fujifilm ultrasonic processor, video processor, light source, other peripheral equipment and endoscopic accessories. It is not intended for use on children and infants.
Catalog Number
-
Brand Name
FUJIFILM
Version/Model Number
EB-530US
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
EOQ
Product Code Name
BRONCHOSCOPE (FLEXIBLE OR RIGID)
Public Device Record Key
f9930df0-ea35-4669-b2cb-2e0cf225fd9e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 14, 2016
Package DI Number
14547410330189
Quantity per Package
1
Contains DI Package
04547410330182
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 |