Catalog Number

-

Brand Name

BRACHYTHERAPY NEEDLE

Version/Model Number

GM1031-1812

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

K103449,K103449,K103449,K103449

Product Code

KXK

Product Code Name

Source, Brachytherapy, Radionuclide

Public Device Record Key

e017a1d4-7093-415b-8cf8-d13d1dea392d

Public Version Date

July 18, 2018

Public Version Number

6

DI Record Publish Date

August 31, 2017

Package DI Number

20812444026997

Quantity per Package

9

Contains DI Package

00812444026993

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-