Catalog Number

12-45-L18

Brand Name

Interspinous Plate

Version/Model Number

12-45-L18

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PEK

Product Code Name

Spinous Process Plate

Public Device Record Key

4a7a7f1d-0021-4b91-986f-b87369dd65d6

Public Version Date

April 23, 2019

Public Version Number

3

DI Record Publish Date

December 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-