Catalog Number

-

Brand Name

SENSAT.R.A.C.™

Version/Model Number

M8275057/10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K062227,K062227

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

53cc1ad8-13d2-4d6c-b40b-3e798999ac76

Public Version Date

September 09, 2020

Public Version Number

5

DI Record Publish Date

November 22, 2017

Package DI Number

00878237001134

Quantity per Package

10

Contains DI Package

00878237001141

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

10 Pack