Catalog Number

66021811

Brand Name

Renasys

Version/Model Number

66021811

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

-

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

K142979,K142979

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

c5751456-6c97-4d4b-b580-7a033788aa3f

Public Version Date

June 22, 2021

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

05000223491499

Quantity per Package

1

Contains DI Package

00040565127293

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case