Catalog Number

-

Brand Name

ACTAMAX

Version/Model Number

AX-310

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

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

10d321a2-d447-43e7-8659-1875a278a32f

Public Version Date

March 19, 2019

Public Version Number

1

DI Record Publish Date

March 11, 2019

Package DI Number

20815634020843

Quantity per Package

1

Contains DI Package

10815634020846

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE