Catalog Number

7020-1571

Brand Name

PerfIC Cath™

Version/Model Number

7020-1571

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

EZD

Product Code Name

Catheter, Straight

Public Device Record Key

e7afc2ec-64fb-4a11-9983-10a6e86ed2d8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 28, 2016

Package DI Number

00851847007062

Quantity per Package

100

Contains DI Package

00851847007055

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case of 100 units.