Catalog Number

-

Brand Name

Cephus Catheter

Version/Model Number

0006560

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

-

Product Code

FCE

Product Code Name

Enema kit

Public Device Record Key

e23d1b78-3fcb-455b-b15e-144cbff2a675

Public Version Date

July 22, 2019

Public Version Number

2

DI Record Publish Date

November 30, 2018

Package DI Number

10860000559130

Quantity per Package

10

Contains DI Package

00860000559133

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box