Duns Number:627879687
Device Description: The Bipolar Hemostatic Probe is passed through an endoscope's working channel to provide h The Bipolar Hemostatic Probe is passed through an endoscope's working channel to provide hemostasis throughout the gastrointestinal tract.
Catalog Number
00711847
Brand Name
NA
Version/Model Number
00711847
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2020
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
K102273
Product Code
KNS
Product Code Name
Unit, electrosurgical, endoscopic (with or without accessories)
Public Device Record Key
5f9ce875-a80d-474e-8251-d5fdd0a9b370
Public Version Date
March 31, 2020
Public Version Number
7
DI Record Publish Date
September 17, 2016
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 | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |