Duns Number:627879687
Device Description: The Polyp Pak includes 1 Rotator snare - oval and 1 Roth Net retriever - polyp. The Rotat The Polyp Pak includes 1 Rotator snare - oval and 1 Roth Net retriever - polyp. The Rotator snare is an electrosurgical device used to grasp, dissect and transect tissue during gastrointestinal endoscopic procedures, and used with diathermic energy. The Roth Net retriever is used in the endoscopic retrieval of foreign body, food bolus and excised tissue such as polyps.
Catalog Number
00711091
Brand Name
Polyp Pak
Version/Model Number
00711091
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
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
63a33f70-5df3-4111-a43c-f4bb2e1ff52c
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
March 19, 2020
Package DI Number
10724995182547
Quantity per Package
5
Contains DI Package
00724995182540
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 |