Catalog Number

-

Brand Name

ReliaTect® Post-Op Dressing with CHG

Version/Model Number

0496-0568-76

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K163529,K163529,K163529

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

aeb48982-bf91-4910-bb32-d6db6fd7e94e

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

August 31, 2018

Package DI Number

20817138010511

Quantity per Package

5

Contains DI Package

10817138010514

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tertiary (Shipper)