Catalog Number

-

Brand Name

Centurion

Version/Model Number

DC80100AST

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

9c606aef-60a4-4676-9c60-4cba065ea63b

Public Version Date

December 22, 2021

Public Version Number

5

DI Record Publish Date

July 21, 2017

Package DI Number

00653160311303

Quantity per Package

5

Contains DI Package

10653160311300

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE