Duns Number:315304071
Device Description: NEPHROSCOPE 12° 20.8FR WL 224MM rigid, with parallel ocular lens, working channel for ins NEPHROSCOPE 12° 20.8FR WL 224MM rigid, with parallel ocular lens, working channel for instruments up to 10.5Fr, TL 387mm, rod lens system
Catalog Number
8964.401
Brand Name
PANOVIEW
Version/Model Number
8964401
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FGA
Product Code Name
Kit, nephroscope
Public Device Record Key
83a86ad3-4ced-486f-883a-e9ebb695c0c1
Public Version Date
April 28, 2021
Public Version Number
5
DI Record Publish Date
September 23, 2016
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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |