Duns Number:354059073
Device Description: Single Use Urinary Catheter LoFric Sense Nelaton 15cm CH12 / Nelaton 6" 12FR
Catalog Number
4161250
Brand Name
LoFric® Sense™
Version/Model Number
4161250
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
EZD
Product Code Name
CATHETER, STRAIGHT
Public Device Record Key
67a1fe78-33be-4fa6-bd0c-fdab1de320af
Public Version Date
January 15, 2021
Public Version Number
3
DI Record Publish Date
November 23, 2016
Package DI Number
07392532180149
Quantity per Package
4
Contains DI Package
07392532086373
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Transport Packaging
| 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 |