Catalog Number

SC02

Brand Name

Rospital Productos Medicos

Version/Model Number

SC02

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

FXP

Product Code Name

Cover, Shoe, Operating-Room

Public Device Record Key

7daaa99b-efae-4584-80f6-63467c6c3437

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

September 29, 2020

Package DI Number

30812460028255

Quantity per Package

10

Contains DI Package

00812460028254

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE