Catalog Number

XMSGP030A10.02-001

Brand Name

GammaPod™ Breast Immobilization and Localization System

Version/Model Number

Inner Breast Cup

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

K180571,K180571

Product Code

IWB

Product Code Name

System, Radiation Therapy, Radionuclide

Public Device Record Key

5d77a250-add2-4b69-96d6-aa8c37b9a678

Public Version Date

March 29, 2019

Public Version Number

1

DI Record Publish Date

March 21, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-