Catalog Number

-

Brand Name

BI-OK Steam Vials (20/pack)

Version/Model Number

26920000

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

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

K891784,K891784

Product Code

FRC

Product Code Name

Indicator, Biological Sterilization Process

Public Device Record Key

c60a8d84-ad6c-47b1-b690-e7947b3e6f3f

Public Version Date

March 19, 2019

Public Version Number

1

DI Record Publish Date

March 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-