Catalog Number

-

Brand Name

IsoSeed® I-125, unsterile, loose, high activity

Version/Model Number

I25.S17PLUS-ULH

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 05, 2016

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K140849

Product Code

KXK

Product Code Name

Source, Brachytherapy, Radionuclide

Public Device Record Key

fc42ddc3-abe5-459b-b014-41e5fdbc42ce

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-