Catalog Number

DUP86644

Brand Name

XTRASORB®

Version/Model Number

86644

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

99676573-ac0a-4160-871b-8bc0a0dfebd5

Public Version Date

June 22, 2021

Public Version Number

4

DI Record Publish Date

August 31, 2018

Package DI Number

00809958186824

Quantity per Package

4

Contains DI Package

00809958186817

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case