Duns Number:839138955
Device Description: A semi-rigid forcep inserted through the working channel of an endoscope to grasp tissue o A semi-rigid forcep inserted through the working channel of an endoscope to grasp tissue or other foreign bodies. It has a leur port for cleaning.
Catalog Number
HS2335
Brand Name
AED Hystero Pointed Scissor, Single Action
Version/Model Number
HS2335
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HIH
Product Code Name
Hysteroscope (And Accessories)
Public Device Record Key
b8762466-7db7-4922-84fd-c9605ba6121c
Public Version Date
July 21, 2021
Public Version Number
1
DI Record Publish Date
July 13, 2021
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 | 579 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6418 |