Catalog Number

84-0504

Brand Name

VertebraLINK

Version/Model Number

84-0504

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GAC

Product Code Name

Rasp, Surgical, General & Plastic Surgery

Public Device Record Key

09e7b59c-e68a-48e9-8df8-09f87e411e09

Public Version Date

November 28, 2018

Public Version Number

4

DI Record Publish Date

April 24, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-