Catalog Number

SSR13B-01

Brand Name

SCOUT Bx™

Version/Model Number

00884450564943

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

-

Product Code

NEU

Product Code Name

MARKER, RADIOGRAPHIC, IMPLANTABLE

Public Device Record Key

35ce9e97-0b3a-4949-9e5f-a0b5c75e4dd5

Public Version Date

September 08, 2022

Public Version Number

1

DI Record Publish Date

August 31, 2022

Package DI Number

10884450564940

Quantity per Package

5

Contains DI Package

00884450564943

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-