Duns Number:192559557
Device Description: HYDROPHILIC COATED NEPHROSTOMY LOCKING CATHETER, 8F
Catalog Number
NCL2-0835HB
Brand Name
Nephro-Cath Nephrostomy Drainage Catheter
Version/Model Number
NCL2-0835HB
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
GBO
Product Code Name
Catheter, Nephrostomy, General & Plastic Surgery
Public Device Record Key
f4c4cabb-94e8-416c-b029-de3cf8ca49a8
Public Version Date
May 09, 2022
Public Version Number
1
DI Record Publish Date
April 29, 2022
Package DI Number
10817640021374
Quantity per Package
5
Contains DI Package
00817640021377
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Dispenser
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 179 |
2 | A medical device with a moderate to high risk that requires special controls. | 77 |
U | Unclassified | 24 |