Catalog Number

-

Brand Name

Applicator Needle

Version/Model Number

1100-1812X

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)

Yes

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

Product Code

KXK

Product Code Name

Source, Brachytherapy, Radionuclide

Public Device Record Key

8a0988cb-59b5-4e6d-ac26-40e0613f8953

Public Version Date

May 24, 2019

Public Version Number

4

DI Record Publish Date

November 02, 2017

Package DI Number

10812444027317

Quantity per Package

5

Contains DI Package

00812444027310

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-