Catalog Number

10830001

Brand Name

MapPHAN (10cm)

Version/Model Number

10830001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

IXG

Product Code Name

Phantom, Anthropomorphic, Radiographic

Public Device Record Key

007cc85d-6a1e-4a26-a003-27aa3cefdddb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-