Catalog Number

UN1083S

Brand Name

Negative Pressure Wound Therapy System Foam Dressing

Version/Model Number

UN1083S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

178cde74-19e8-481f-90fb-7eb048f6d520

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

February 05, 2019

Package DI Number

B530UN1083S1

Quantity per Package

20

Contains DI Package

B530UN1083S0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box