Catalog Number

926000

Brand Name

Mammosite Cavity Evaluation Device Kit (CED)

Version/Model Number

926000

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

K081179,K081179

Product Code

JAQ

Product Code Name

System, applicator, radionuclide, remote-controlled

Public Device Record Key

df1582ee-3310-4b75-8d2c-ce66a3b7b871

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 04, 2016

Package DI Number

25420045505015

Quantity per Package

1

Contains DI Package

15420045505018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX