Catalog Number

SF-S16-851

Brand Name

SUPRA-FOLEY

Version/Model Number

16Fr Introducer

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"

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

K884061,K884061

Product Code

KOB

Product Code Name

Catheter, Suprapubic (And Accessories)

Public Device Record Key

a45deb1d-b88a-413d-8add-5ad5389a1c6a

Public Version Date

December 18, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

H671SFS168511

Quantity per Package

10

Contains DI Package

H671SFS168510

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box