Catalog Number

SG-01/C

Brand Name

SCOUT®

Version/Model Number

00884450434734

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

NEU

Product Code Name

Marker, Radiographic, Implantable

Public Device Record Key

6e2912b0-5ed2-47db-b77f-c62f7f0bc4be

Public Version Date

February 23, 2022

Public Version Number

1

DI Record Publish Date

February 15, 2022

Package DI Number

10884450434731

Quantity per Package

1

Contains DI Package

00884450434734

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-