Catalog Number

SH-01/A

Brand Name

SCOUT®

Version/Model Number

00852205006109

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

5df7455a-fbd6-40d9-a3d9-2b21f7026591

Public Version Date

November 21, 2019

Public Version Number

1

DI Record Publish Date

November 13, 2019

Package DI Number

10852205006106

Quantity per Package

20

Contains DI Package

00852205006109

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-