Catalog Number

-

Brand Name

not applicable

Version/Model Number

M3-2 SP1 STD+

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P130020

Product Code

OTE

Product Code Name

Digital breast tomosynthesis

Public Device Record Key

05d49b6b-56bc-4ec0-b488-3fd069971f44

Public Version Date

July 16, 2018

Public Version Number

1

DI Record Publish Date

June 15, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-