Catalog Number

BSM-5S

Brand Name

NA

Version/Model Number

BSM-5S

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DWS

Product Code Name

Instruments, Surgical, Cardiovascular

Public Device Record Key

a47e4c42-7bb3-4c9b-b813-a5dbe54fce61

Public Version Date

September 14, 2022

Public Version Number

1

DI Record Publish Date

September 06, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-