Catalog Number

SH-01

Brand Name

SAVI SCOUT®

Version/Model Number

SH-01

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)

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

14e18b1b-0896-482a-a498-4ae5c6dbc925

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

November 22, 2017

Package DI Number

10852205006090

Quantity per Package

20

Contains DI Package

00852205006093

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton