Catalog Number

AL09400000

Brand Name

VariSource VS2000 HDR Ir 192 Brachytherapy Sealed Source

Version/Model Number

AL09400000

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K122236

Product Code

JAQ

Product Code Name

System, applicator, radionuclide, remote-controlled

Public Device Record Key

a3a5da28-baa6-4d8a-bd24-5f639f62ac2e

Public Version Date

January 17, 2022

Public Version Number

1

DI Record Publish Date

January 09, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-