Duns Number:690625850
Device Description: The Product is a transparent distal attachment applied to the tip of the endoscope. It is The Product is a transparent distal attachment applied to the tip of the endoscope. It is used in ESD procedures. This Product is used for maintaining visualization during the dissection phase of the procedure. This Product contains drainage side hole that allows egress of water and blood. This Product is disposable and in a variety of diameters that correspond to different endoscope sizes.
Catalog Number
-
Brand Name
SB Soft Hood /Undercut type
Version/Model Number
MD-47961
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
5b1e7b3d-cdf6-4ae1-9078-69ed5b74179a
Public Version Date
May 30, 2022
Public Version Number
3
DI Record Publish Date
September 30, 2018
Package DI Number
24545499068891
Quantity per Package
5
Contains DI Package
04545499068897
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 211 |