Catalog Number

DUP89533

Brand Name

XTRASORB®

Version/Model Number

89533

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NAC

Product Code Name

Dressing, wound, hydrophilic

Public Device Record Key

0359fda4-7025-4841-9692-48881e79d071

Public Version Date

June 22, 2021

Public Version Number

4

DI Record Publish Date

August 31, 2018

Package DI Number

00809958185322

Quantity per Package

10

Contains DI Package

00809958185315

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case