Duns Number:354059073
Device Description: Single Use Urinary Catheter with salt solution. LoFric Sense, Nelaton 15cm CH12 / Nelaton Single Use Urinary Catheter with salt solution. LoFric Sense, Nelaton 15cm CH12 / Nelaton 6" 12FR, 5-pack. For females. Sterile device.
Catalog Number
4161205
Brand Name
LoFric® Sense™
Version/Model Number
4161225
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
EZD
Product Code Name
CATHETER, STRAIGHT
Public Device Record Key
ddb5356d-2341-4625-8c76-aa6fbc3a0292
Public Version Date
February 09, 2021
Public Version Number
2
DI Record Publish Date
October 06, 2018
Package DI Number
07392532183317
Quantity per Package
5
Contains DI Package
07392532086281
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Customer pack
| 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 |