Catalog Number

DUP86344

Brand Name

XTRASORB®

Version/Model Number

86344

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

NAD

Product Code Name

Dressing, wound, occlusive

Public Device Record Key

2d8f1942-5776-4fa7-8126-43b21124f830

Public Version Date

June 22, 2021

Public Version Number

4

DI Record Publish Date

August 31, 2018

Package DI Number

00809958184226

Quantity per Package

4

Contains DI Package

00809958184219

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case