Catalog Number

H5014PM

Brand Name

Invenia

Version/Model Number

ABUS System

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 24, 2015

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P110006,P110006,P110006

Product Code

PAA

Product Code Name

Automated Breast Ultrasound

Public Device Record Key

e7749c6d-be38-4d6e-bd82-e71c00c50991

Public Version Date

May 10, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-