Catalog Number

06.6616B

Brand Name

Dymaxeon®

Version/Model Number

05.5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

Product Code

MNH

Product Code Name

Orthosis, spondylolisthesis spinal fixation

Public Device Record Key

df4ac894-b715-4af4-b86a-1b2d119ccde0

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-