Duns Number:094651270
Device Description: Suprapubic Catheter Introducer Kit, 16 French
Catalog Number
SF-S16-100
Brand Name
SUPRA-FOLEY
Version/Model Number
16Fr Catheterization Kit
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K884061,K884061
Product Code
KOB
Product Code Name
Catheter, Suprapubic (And Accessories)
Public Device Record Key
69abe716-8809-4aa3-b71d-b93fc52e6727
Public Version Date
December 18, 2019
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
H671SFS161001
Quantity per Package
5
Contains DI Package
H671SFS161000
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 35 |
2 | A medical device with a moderate to high risk that requires special controls. | 274 |