Catalog Number

66801277

Brand Name

RENASYS TOUCH

Version/Model Number

66801277

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

K153209,K153209

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

fded9466-3fc4-498b-8330-304311f99051

Public Version Date

August 09, 2019

Public Version Number

4

DI Record Publish Date

November 02, 2016

Package DI Number

30040565126563

Quantity per Package

50

Contains DI Package

00040565126562

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case