Catalog Number

7893

Brand Name

Levó Sterile Cervical Drape w/Window

Version/Model Number

7893-1

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)

-

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

c561f0c4-1e28-4f8b-953e-dee7aaa1f034

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

December 31, 2018

Package DI Number

10842430105057

Quantity per Package

6

Contains DI Package

00842430105050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PKG