Duns Number:627879687
Device Description: The Rotator snare oval is an electrosurgical device used to grasp, dissect and transect ti The Rotator snare oval is an electrosurgical device used to grasp, dissect and transect tissue during gastrointestinal endoscopic procedures, and used with diathermic energy.
Catalog Number
00711120
Brand Name
Rotator
Version/Model Number
00711120
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"
Yes
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
FDI
Product Code Name
SNARE, FLEXIBLE
Public Device Record Key
397ec5cb-e7c9-4a91-9343-252bf489466e
Public Version Date
November 10, 2020
Public Version Number
2
DI Record Publish Date
March 19, 2020
Package DI Number
10724995182646
Quantity per Package
10
Contains DI Package
00724995182649
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |