Catalog Number

-

Brand Name

ASSURE

Version/Model Number

110.034

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K040721

Product Code

KWQ

Product Code Name

APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Public Device Record Key

6e302d01-cb0d-40db-97c6-6160d7651b56

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 07, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-