Catalog Number

PCP50

Brand Name

ETHICON

Version/Model Number

PCP50

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"

-

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

DXZ

Product Code Name

PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Public Device Record Key

34f8049c-5349-41ae-a94c-220fd8ea6535

Public Version Date

July 24, 2019

Public Version Number

3

DI Record Publish Date

September 01, 2015

Package DI Number

20705031047836

Quantity per Package

36

Contains DI Package

10705031047839

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX