Catalog Number

-

Brand Name

Ave 2

Version/Model Number

4BCPPB-GCZ002

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

-

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

HDD

Product Code Name

Table, Obstetrical, Ac-Powered (And Accessories)

Public Device Record Key

0d91d52d-aabf-4641-bb5d-1523008d9e1b

Public Version Date

May 11, 2018

Public Version Number

1

DI Record Publish Date

April 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-