Duns Number:315304071
Device Description: SHEATH FOR NEPHROSCOPE 20.8FR SL 204mm, round, rotatable stopcock, distal end straight, c SHEATH FOR NEPHROSCOPE 20.8FR SL 204mm, round, rotatable stopcock, distal end straight, compatible with nephroscope 8964401, quick-lock, reusable
Catalog Number
8964.021
Brand Name
NA
Version/Model Number
8964021
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
FED
Product Code Name
endoscopic access overtube, gastroenterology-urology
Public Device Record Key
fb91ea04-9e89-4fd7-aa9a-95f802d0ce87
Public Version Date
May 03, 2021
Public Version Number
7
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 |