I-125 SeedsTM in Carrier - MEDI-PHYSICS, INC.

Duns Number:059470927

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

6720-00275

Brand Name

I-125 SeedsTM in Carrier

Version/Model Number

6720 - I-125 Seeds 0.275 mCi

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

KXK

Product Code Name

Source, brachytherapy, radionuclide

Device Record Status

Public Device Record Key

bd9b760d-1e8d-4007-b0a2-8828d70b67b9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDI-PHYSICS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 160