Catalog Number

-

Brand Name

CREO

Version/Model Number

5192.1527

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

K182375

Product Code

KWP

Product Code Name

APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Public Device Record Key

37d3a95a-5a4a-4bdd-ba0b-ce372d7780d3

Public Version Date

July 08, 2019

Public Version Number

1

DI Record Publish Date

June 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-