Catalog Number

MTAPUR142.4

Brand Name

Uni-frame® Thermoplastic

Version/Model Number

MTAPUR142.4

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 16, 2021

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

6ad736b1-3a21-4d62-a1d8-0bd19bb2eee5

Public Version Date

January 18, 2021

Public Version Number

9

DI Record Publish Date

September 25, 2017

Package DI Number

00841439103838

Quantity per Package

5

Contains DI Package

10841439103835

Package Discontinue Date

January 16, 2021

Package Status

Not in Commercial Distribution

Package Type

-