Catalog Number

6715-00414

Brand Name

I-125 SeedTM Sterile Convenience Pack

Version/Model Number

6715 - I-125 Seed 0.414mCi

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IWG

Product Code Name

Seed, isotope, gold, titanium, platinum

Public Device Record Key

aa81e0fb-1d38-4e72-8f66-6b0759fab216

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-