Catalog Number

-

Brand Name

Medi-Roller

Version/Model Number

TMR6270

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FMR

Product Code Name

DEVICE, TRANSFER, PATIENT, MANUAL

Public Device Record Key

a392dd94-3585-4c46-a718-d138eab30a7d

Public Version Date

November 26, 2019

Public Version Number

1

DI Record Publish Date

November 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-