Catalog Number

A400-MAYO

Brand Name

AD Surgical

Version/Model Number

A400-MAYO

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

PUI

Product Code Name

Drape, Surgical, Exempt

Public Device Record Key

c14bd2be-bc67-4ff4-8427-30f2928b0d67

Public Version Date

February 28, 2022

Public Version Number

1

DI Record Publish Date

February 18, 2022

Package DI Number

10814639025672

Quantity per Package

10

Contains DI Package

00814639025675

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box