Catalog Number

PCC046

Brand Name

VERIFY

Version/Model Number

PCC046

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 2019

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K091174,K091174

Product Code

JOJ

Product Code Name

Indicator, physical/chemical sterilization process

Public Device Record Key

b3851546-5fdb-499a-98ad-62ca2b08597c

Public Version Date

February 19, 2021

Public Version Number

6

DI Record Publish Date

September 06, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-