VariStrand with OncoSeed - VariStrand with OncoSeed, x = 1-12 seeds and 0 - THERAGENICS CORPORATION

Duns Number:114379522

Device Description: VariStrand with OncoSeed, x = 1-12 seeds and 0 or more spacers

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


More Product Details

Catalog Number

-

Brand Name

VariStrand with OncoSeed

Version/Model Number

ON772xi

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K023179

Product Code Details

Product Code

KXK

Product Code Name

Source, Brachytherapy, Radionuclide

Device Record Status

Public Device Record Key

64974206-0f0d-497f-99c5-3c4ce59fa521

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 10, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"THERAGENICS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38
2 A medical device with a moderate to high risk that requires special controls. 144