Catalog Number

ZP6553120

Brand Name

Proteger

Version/Model Number

ZP6553120

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)

Yes

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

3716765c-9aaf-4253-8982-cb297ca6de6e

Public Version Date

May 11, 2021

Public Version Number

1

DI Record Publish Date

May 03, 2021

Package DI Number

17466532979144

Quantity per Package

10

Contains DI Package

07466532979147

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case