Catalog Number

3-5025

Brand Name

Hospital Packs

Version/Model Number

10e5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 17, 2016

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)

Yes

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

K020026,K020026

Product Code

FRC

Product Code Name

Indicator, Biological Sterilization Process

Public Device Record Key

a722b67c-7bb6-42c5-81ea-5b20eb4de8ef

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-