Catalog Number

M1128-ODK

Brand Name

Rampart

Version/Model Number

M1128-ODK

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)

Yes

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

965f4442-f635-42d8-87f7-e13eb2b177de

Public Version Date

April 15, 2021

Public Version Number

1

DI Record Publish Date

April 07, 2021

Package DI Number

17466532979229

Quantity per Package

10

Contains DI Package

07466532979222

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case