Catalog Number

SSR10-01/D

Brand Name

SCOUT®

Version/Model Number

00884450434796

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

b65829f8-47eb-4814-bdc4-ed9a66a6d37e

Public Version Date

October 11, 2021

Public Version Number

2

DI Record Publish Date

January 19, 2021

Package DI Number

20884450434790

Quantity per Package

16

Contains DI Package

10884450434793

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-