Duns Number:713565195
Device Description: This product is a medical ultrasonic probe. It is intended for the observation and diagnos This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract, airways and tracheobronchial tree under the management of physicians at medical facilities.
Catalog Number
-
Brand Name
FUJIFILM
Version/Model Number
PB2020-M
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
ITX
Product Code Name
Transducer, Ultrasonic, Diagnostic
Public Device Record Key
78dffc7b-4a2b-4611-8b2b-232188573bdc
Public Version Date
May 23, 2018
Public Version Number
3
DI Record Publish Date
February 23, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |