Catalog Number

-

Brand Name

GLOBAL HEALTHCARE

Version/Model Number

07-21XL

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

b12231fa-4051-4eb9-88b8-2c3609da7f21

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

August 04, 2020

Package DI Number

40872237009174

Quantity per Package

26

Contains DI Package

00872237009138

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE