Duns Number:627879687
Device Description: The disposable Roth Net foreign body maxi retrieval device is used in the endoscopic retri The disposable Roth Net foreign body maxi retrieval device is used in the endoscopic retrieval of foreign body, food bolus and excised tissue such as polyps.
Catalog Number
00711059
Brand Name
Roth Net
Version/Model Number
00711059
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
15da9dbd-1ada-471d-9613-16070f5d997e
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
March 19, 2020
Package DI Number
10724995182530
Quantity per Package
5
Contains DI Package
00724995182533
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 |