Catalog Number

46.4245

Brand Name

Dymaxeon

Version/Model Number

05.5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 12, 2019

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

16b9b5db-c660-4a72-9fef-f2378f784730

Public Version Date

March 09, 2020

Public Version Number

2

DI Record Publish Date

March 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-