Catalog Number

-

Brand Name

INTRABEAM® Spherical Applicator 1.5 cm

Version/Model Number

304534-6000-557

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K121653

Product Code

JAD

Product Code Name

System, Therapeutic, X-Ray

Public Device Record Key

990603e5-a390-4076-8690-7c695d8434a0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-