Duns Number:796986144
Device Description: PROG 8840 N'VISION PHYSCN HNDHLD RFRB US
Catalog Number
-
Brand Name
N'VISION™
Version/Model Number
8840
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"
-
For Single-Use
-
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
P840001
Product Code
EZW
Product Code Name
Stimulator, electrical, implantable, for incontinence
Public Device Record Key
3e681c0b-80c5-4948-9b73-a25682a9fabc
Public Version Date
July 07, 2020
Public Version Number
5
DI Record Publish Date
October 02, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |