Duns Number:627879687
Device Description: The disposable Roth Net Platinum polyp retrieval device product line is used in the endosc The disposable Roth Net Platinum polyp retrieval device product line is used in the endoscopic retrieval of foreign body, food bolus and excised tissue such as polyps.
Catalog Number
00715150
Brand Name
Roth Net Platinum
Version/Model Number
00715150
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
K122462,K122462
Product Code
FDI
Product Code Name
SNARE, FLEXIBLE
Public Device Record Key
414e97c9-39b4-471e-91c7-b012c8853d4b
Public Version Date
April 07, 2021
Public Version Number
6
DI Record Publish Date
September 17, 2016
Package DI Number
10816765011994
Quantity per Package
5
Contains DI Package
00816765011997
Package Discontinue Date
March 31, 2020
Package Status
Not 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 |