Catalog Number

-

Brand Name

U.L.I.S™

Version/Model Number

IS1-ID

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

KWP

Product Code Name

Appliance, Fixation, Spinal Interlaminal

Public Device Record Key

760ccc9c-fc75-4305-a2f2-28f336be5d4a

Public Version Date

October 05, 2018

Public Version Number

1

DI Record Publish Date

September 04, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-