Duns Number:627879687
Device Description: The CoinTip snare is an electrosurgical device designed to be used to endoscopically grasp The CoinTip snare is an electrosurgical device designed to be used to endoscopically grasp, dissect, and transect tissue during Gastrointestinal (GI) endoscopic procedures. The snare can be used with or without the use of monopolar diathermic energy.
Catalog Number
00711415
Brand Name
CoinTip
Version/Model Number
00711415
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
e38a3a94-717f-41ec-919f-226eb568138a
Public Version Date
November 10, 2020
Public Version Number
2
DI Record Publish Date
June 11, 2020
Package DI Number
10724995194373
Quantity per Package
20
Contains DI Package
00724995194376
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 | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |