Catalog Number

-

Brand Name

AD Surgical

Version/Model Number

A400-UTD

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

2d2026da-7e7d-4f11-a8a0-da1eec5f0df4

Public Version Date

June 22, 2021

Public Version Number

3

DI Record Publish Date

January 15, 2021

Package DI Number

10814639022084

Quantity per Package

20

Contains DI Package

00814639022087

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box