Catalog Number

-

Brand Name

Acessa Pads

Version/Model Number

3000

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HFG

Product Code Name

Coagulator, Laparoscopic, Unipolar (And Accessories)

Public Device Record Key

211ab9b3-f8a4-4323-8624-7dcbcdd5011c

Public Version Date

March 02, 2021

Public Version Number

3

DI Record Publish Date

October 11, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-