Duns Number:627879687
Device Description: The disposable Roth Net Platinum polyp, sterile retrieval device product line is used in t The disposable Roth Net Platinum polyp, sterile retrieval device product line is used in the endoscopic retrieval of foreign body, food bolus and excised tissue such as polyps.
Catalog Number
00715160
Brand Name
Roth Net Platinum
Version/Model Number
00715160
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"
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
K122462,K122462
Product Code
FDI
Product Code Name
SNARE, FLEXIBLE
Public Device Record Key
d7e0e6e0-ed5f-4028-83bf-7cc405cfec7a
Public Version Date
April 07, 2021
Public Version Number
6
DI Record Publish Date
September 17, 2016
Package DI Number
10816765012007
Quantity per Package
5
Contains DI Package
00816765012000
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 |