Duns Number:627879687
Device Description: The disposable Roth Net Platinum food bolus retrieval device is used in the endoscopic ret The disposable Roth Net Platinum food bolus retrieval device is used in the endoscopic retrieval food bolus.
Catalog Number
00711155
Brand Name
Roth Net Platinum
Version/Model Number
00711155
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"
-
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
a8558c85-3b47-4842-a9ad-faad018f5808
Public Version Date
April 07, 2021
Public Version Number
6
DI Record Publish Date
September 17, 2016
Package DI Number
10816765011277
Quantity per Package
5
Contains DI Package
00816765011270
Package Discontinue Date
March 17, 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 |