Duns Number:354059073
Device Description: Single Use Urinary Catheter with water sachet. Male Nelaton 16" 12FR
Catalog Number
5401200
Brand Name
SimPro™ Core
Version/Model Number
5401200
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 14, 2022
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EZD
Product Code Name
CATHETER, STRAIGHT
Public Device Record Key
46f990c2-bd9b-48a0-93c1-18355802bb82
Public Version Date
May 09, 2022
Public Version Number
2
DI Record Publish Date
February 26, 2019
Package DI Number
07392532194559
Quantity per Package
4
Contains DI Package
07392532194542
Package Discontinue Date
April 13, 2022
Package Status
Not 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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |