Catalog Number

-

Brand Name

ABTHERA ADVANCE™

Version/Model Number

ABT1055

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

K120499,K120499

Product Code

OMP

Product Code Name

Negative Pressure Wound Therapy Powered Suction Pump

Public Device Record Key

2ebf31ed-71d0-4e5c-b121-6aa143835214

Public Version Date

September 09, 2020

Public Version Number

2

DI Record Publish Date

July 04, 2018

Package DI Number

00849554006942

Quantity per Package

5

Contains DI Package

00849554006966

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

5 PACK