Catalog Number

-

Brand Name

CI UNIVERSAL DRAPE

Version/Model Number

SD-2300

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

d0ebaf28-9f5b-4004-8f89-55767096c10c

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

November 19, 2021

Package DI Number

10850000126166

Quantity per Package

6

Contains DI Package

00850000126169

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-