Catalog Number

MTVRTR

Brand Name

Uni-frame® Thermoplastic

Version/Model Number

MTVRTR

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

K080072,K093738,K933227,K080072,K093738,K933227

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Public Device Record Key

bfb4d143-9056-4813-b8b9-7ec0883e22b2

Public Version Date

August 03, 2020

Public Version Number

7

DI Record Publish Date

September 25, 2017

Package DI Number

00841439108871

Quantity per Package

5

Contains DI Package

10841439108878

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-