Duns Number:022760922
Device Description: 8.0 Fr. Silicone Urinary Collection Kit with catheter
Catalog Number
-
Brand Name
NC30800T
Version/Model Number
NC30800T
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
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
LRO
Product Code Name
General Surgery Tray
Public Device Record Key
05ec82dd-d957-41dc-8ac5-50dd743a2eb4
Public Version Date
December 04, 2020
Public Version Number
4
DI Record Publish Date
February 19, 2018
Package DI Number
10816336021018
Quantity per Package
5
Contains DI Package
10816336020387
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 112 |