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)

Yes

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

FCE

Product Code Name

Enema kit

Public Device Record Key

98e7d208-1d02-477a-8f43-8bc80ab15f9b

Public Version Date

July 22, 2019

Public Version Number

2

DI Record Publish Date

November 30, 2018

Package DI Number

10860000559116

Quantity per Package

10

Contains DI Package

00860000559119

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box