Duns Number:354059073
Device Description: Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 10FR Paediatric
Catalog Number
42110403
Brand Name
LoFric® Hydro-Kit™
Version/Model Number
42110
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
12acbdb7-86e6-4680-9d22-cce1f3ba9698
Public Version Date
December 14, 2020
Public Version Number
1
DI Record Publish Date
December 04, 2020
Package DI Number
07392532247453
Quantity per Package
30
Contains DI Package
07392532250545
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |