Catalog Number

0506-482-000

Brand Name

PCD

Version/Model Number

0506482000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 09, 2021

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

JDZ

Product Code Name

MIXER, CEMENT, FOR CLINICAL USE

Public Device Record Key

04eebd22-ad0d-45cd-ac70-6bd8042ca89e

Public Version Date

October 25, 2021

Public Version Number

2

DI Record Publish Date

September 24, 2018

Package DI Number

34546540906992

Quantity per Package

4

Contains DI Package

04546540906991

Package Discontinue Date

July 09, 2021

Package Status

Not in Commercial Distribution

Package Type

pack