Duns Number:713565195
Device Description: This product is intended to be used in combination with the FUJIFILM ultrasonic endoscope This product is intended to be used in combination with the FUJIFILM ultrasonic endoscope to enclose the ultrasonic transmission medium in medical facilities under the management of physicians. Do not use this product for any other purpose. This product is not intended for use on children and infants.
Catalog Number
-
Brand Name
FUJIFILM
Version/Model Number
BS-102
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FDS
Product Code Name
Gastroscope And Accessories, Flexible/Rigid
Public Device Record Key
f9fecaaa-285c-45e4-81b7-9a2fcf20eb22
Public Version Date
September 27, 2022
Public Version Number
1
DI Record Publish Date
September 19, 2022
Package DI Number
14547410446149
Quantity per Package
20
Contains DI Package
04547410446142
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 |