Duns Number:021717889
Device Description: Catheter Cuff
Catalog Number
-
Brand Name
Percufix™ Catheter Cuff
Version/Model Number
M001207000
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
KOD
Product Code Name
CATHETER, UROLOGICAL
Public Device Record Key
b031dedd-f186-4244-b2a8-0dad3cfbaf7c
Public Version Date
July 22, 2019
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
08714729115526
Quantity per Package
10
Contains DI Package
08714729735519
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 | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |