Catalog Number

SSR05-01/C

Brand Name

SCOUT®

Version/Model Number

00884450434871

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

c665bf08-ba54-4a77-9b03-a33d1ed815f6

Public Version Date

October 11, 2021

Public Version Number

2

DI Record Publish Date

April 15, 2021

Package DI Number

20884450434875

Quantity per Package

16

Contains DI Package

10884450434878

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-