Duns Number:627879687
Device Description: The iSnare hexagonal system is a dual lumen device providing both needle injection and mon The iSnare hexagonal system is a dual lumen device providing both needle injection and monopolar electrocautery polypectomy snare capability within a single catheter device.
Catalog Number
00711088
Brand Name
iSnare
Version/Model Number
00711088
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
FBK
Product Code Name
endoscopic injection needle, gastroenterology-urology
Public Device Record Key
314bcfd8-0b72-4aed-b2c8-83496168aefb
Public Version Date
November 10, 2020
Public Version Number
2
DI Record Publish Date
March 19, 2020
Package DI Number
10724995180819
Quantity per Package
5
Contains DI Package
00724995180812
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 |