Catalog Number

-

Brand Name

Maddox Defense

Version/Model Number

MDSurg4-XL

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"

Yes

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

FYA

Product Code Name

Gown, Surgical

Public Device Record Key

dc47ab4e-e15b-4ddf-8146-d2a15c5753a2

Public Version Date

March 22, 2022

Public Version Number

1

DI Record Publish Date

March 14, 2022

Package DI Number

10850038889088

Quantity per Package

50

Contains DI Package

00850038889081

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case