Catalog Number

PRO320

Brand Name

ProForm™ MR Overlay

Version/Model Number

PRO320

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K180021

Product Code

LNH

Product Code Name

System, nuclear magnetic resonance imaging

Public Device Record Key

f24069d3-e4b9-4f81-bb7b-edc0485e160a

Public Version Date

November 27, 2020

Public Version Number

1

DI Record Publish Date

November 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-