Duns Number:305524696
Device Description: Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Tapered Tip Coude w/Guide Stripe. Mal Self-Cath Plus. Urinary Catheter. Hydrophilic-coated Tapered Tip Coude w/Guide Stripe. Male. FR 12. 16 in. 40 cm. Rx only.
Catalog Number
50512
Brand Name
Self-Cath
Version/Model Number
50512
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
K003784,K003784,K003784
Product Code
EZD
Product Code Name
CATHETER, STRAIGHT
Public Device Record Key
e4768250-d553-4519-bce4-e9ed970f9083
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 02, 2016
Package DI Number
05708932279857
Quantity per Package
30
Contains DI Package
05708932575874
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Retail box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 46 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 899 |
| 3 | A medical device with high risk that requires premarket approval | 72 |
| U | Unclassified | 7 |