Catalog Number

06.3445B

Brand Name

Dymaxeon®

Version/Model Number

06.0

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 14, 2016

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K121786,K121786

Product Code

MNH

Product Code Name

Orthosis, spondylolisthesis spinal fixation

Public Device Record Key

dc6423f0-d682-4759-8a8b-428e8e335585

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-