Duns Number:627879687
Device Description: The Roth Net retriever-360 product line is intended to be used to retrieve excised polyps, The Roth Net retriever-360 product line is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.
Catalog Number
00711197
Brand Name
Roth Net
Version/Model Number
00711197
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 17, 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
K182909,K182909
Product Code
FDI
Product Code Name
SNARE, FLEXIBLE
Public Device Record Key
29754e7b-15dc-4c53-8bec-553fdcba113c
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
February 19, 2019
Package DI Number
10816765013653
Quantity per Package
5
Contains DI Package
00816765013656
Package Discontinue Date
March 17, 2020
Package Status
Not 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 |