Catalog Number

DD161444C

Brand Name

NA

Version/Model Number

DD161444C

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

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

PLR

Product Code Name

Spinal Vertebral Body Replacement Device - Cervical

Public Device Record Key

efab9698-786a-45fb-8476-62b6a6b3c850

Public Version Date

August 10, 2021

Public Version Number

1

DI Record Publish Date

August 02, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-