Catalog Number

SAVI-06/B

Brand Name

SAVI®

Version/Model Number

00884450434239

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

JAQ

Product Code Name

System, applicator, radionuclide, remote-controlled

Public Device Record Key

d247f729-0a1d-4350-8486-d012ec1941b1

Public Version Date

October 11, 2021

Public Version Number

2

DI Record Publish Date

November 20, 2019

Package DI Number

10884450434236

Quantity per Package

11

Contains DI Package

00884450434239

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-