Catalog Number

-

Brand Name

Centurion

Version/Model Number

8575F138

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"

Yes

For Single-Use

Yes

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

KKX

Product Code Name

Drape, surgical

Public Device Record Key

1fbd6957-50a8-4332-8720-2d88a1cfb35d

Public Version Date

November 08, 2018

Public Version Number

3

DI Record Publish Date

August 31, 2016

Package DI Number

50653160052706

Quantity per Package

400

Contains DI Package

00653160052701

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE