Catalog Number

SAVI-08/B

Brand Name

SAVI®

Version/Model Number

00884450434277

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

dc3fe7df-2b47-4511-8937-5df78097b9b1

Public Version Date

October 11, 2021

Public Version Number

2

DI Record Publish Date

November 14, 2019

Package DI Number

10884450434274

Quantity per Package

11

Contains DI Package

00884450434277

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-