Catalog Number

00-9910-301-12

Brand Name

TOTALSHIELD®

Version/Model Number

00-9910-301-12

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)

Yes

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

26b05dba-56a2-4438-8faa-2ed3165967ae

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 07, 2017

Package DI Number

00889024464698

Quantity per Package

36

Contains DI Package

00889024464681

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX