Catalog Number

00992041210

Brand Name

TotalShield® II Zippered Surgical Toga, XL

Version/Model Number

00992041210

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

040e771f-5966-4afa-99ee-42b071279e50

Public Version Date

December 26, 2019

Public Version Number

1

DI Record Publish Date

December 18, 2019

Package DI Number

00889024553736

Quantity per Package

20

Contains DI Package

00889024553507

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-