Catalog Number

SG-02/B

Brand Name

SCOUT®

Version/Model Number

00884450464465

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

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

f0de3dc4-e13a-4004-9986-ad4153673e90

Public Version Date

October 11, 2021

Public Version Number

2

DI Record Publish Date

June 10, 2020

Package DI Number

10884450464462

Quantity per Package

1

Contains DI Package

00884450464465

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-