Catalog Number

HPSU-01

Brand Name

SAVI SCOUT®

Version/Model Number

HPSU-01

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)

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

df6f09bf-061b-4995-8348-6ab5fa84b915

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

November 22, 2017

Package DI Number

10852205006045

Quantity per Package

5

Contains DI Package

00852205006048

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton