Catalog Number

-

Brand Name

Brachytherapy Needle

Version/Model Number

1105-1820-3

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K103449,K103449

Product Code

KXK

Product Code Name

Source, Brachytherapy, Radionuclide

Public Device Record Key

cb606f84-a5ea-4746-95e3-2c0c86bd29f3

Public Version Date

November 28, 2019

Public Version Number

1

DI Record Publish Date

November 20, 2019

Package DI Number

10810020082187

Quantity per Package

10

Contains DI Package

00810020082180

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-