Catalog Number

-

Brand Name

Portex

Version/Model Number

CE423

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 27, 2019

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"

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

MQF

Product Code Name

CATHETER, ASSISTED REPRODUCTION

Public Device Record Key

ea2c2cc6-d090-43f6-b447-fbdee7610bb4

Public Version Date

October 16, 2019

Public Version Number

4

DI Record Publish Date

October 23, 2017

Package DI Number

35019315012598

Quantity per Package

10

Contains DI Package

15019315012594

Package Discontinue Date

September 27, 2019

Package Status

Not in Commercial Distribution

Package Type

Carton