Catalog Number

AY759X1

Brand Name

BT Sure

Version/Model Number

AY759X1

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"

Yes

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

-

Product Code

FRC

Product Code Name

Indicator, Biological Sterilization Process

Public Device Record Key

bfa0a6eb-af6c-4e13-80e5-4bb528638253

Public Version Date

July 08, 2019

Public Version Number

1

DI Record Publish Date

June 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-