Catalog Number

66800391

Brand Name

NPWT Antimicrobial Large Gauze Roll

Version/Model Number

66800391

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

-

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

K142979,K142979

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

f11408e7-3429-4aba-a14e-7fc827b25e79

Public Version Date

August 24, 2021

Public Version Number

7

DI Record Publish Date

September 20, 2016

Package DI Number

30040565124224

Quantity per Package

10

Contains DI Package

00040565124223

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case