Catalog Number

-

Brand Name

P/Z QC V2 LOW

Version/Model Number

P/Z QC V2 L U F ML

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

LAS

Product Code Name

Drug Specific Control Materials

Public Device Record Key

2887d50c-15a3-4f26-9d73-231a1df3877b

Public Version Date

June 21, 2022

Public Version Number

1

DI Record Publish Date

June 10, 2022

Package DI Number

B80002942500101

Quantity per Package

4

Contains DI Package

B80002942500100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box