Catalog Number

11576-000064

Brand Name

Lucas PCI Back Plate

Version/Model Number

11576

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DRM

Product Code Name

COMPRESSOR, CARDIAC, EXTERNAL

Public Device Record Key

097bcc7a-a20b-4399-90a1-8a93319d00e7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 04, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-