Catalog Number

1122AZ

Brand Name

Adaptor Plate for GMF

Version/Model Number

1122AZ

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 14, 2019

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

K131466

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

7d701cd5-05ce-48c4-9e9f-a7a4fbf20413

Public Version Date

June 14, 2019

Public Version Number

5

DI Record Publish Date

January 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-