Catalog Number

-

Brand Name

AngioSystems Pressure Dressing

Version/Model Number

8000

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

-

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

-

FDA Premarket Submission

K864688,K864688

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

2b490f52-2a86-4e86-a26d-e7bd70474f44

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

September 03, 2018

Package DI Number

00816611024904

Quantity per Package

25

Contains DI Package

00816611024898

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-