Catalog Number

07.00896.701

Brand Name

Invizia

Version/Model Number

07.00896.701

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KWQ

Product Code Name

Appliance, Fixation, Spinal Intervertebral Body

Public Device Record Key

0d1ea819-5dcf-4308-8e9d-18e0c9e748d6

Public Version Date

March 10, 2022

Public Version Number

5

DI Record Publish Date

May 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-