Duns Number:354059073
Device Description: Single Use Urinary Catheter with salt solution. LoFric Origo, Nelaton 30cm CH08 / Nelaton Single Use Urinary Catheter with salt solution. LoFric Origo, Nelaton 30cm CH08 / Nelaton 12" 08FR, Sterile device.
Catalog Number
44208
Brand Name
LoFric® Origo™
Version/Model Number
44208
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
8318670e-e196-4632-8f19-9acdbac2e248
Public Version Date
October 04, 2018
Public Version Number
5
DI Record Publish Date
January 20, 2017
Package DI Number
07392532156236
Quantity per Package
4
Contains DI Package
07392532156229
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 |