Catalog Number

7894-6

Brand Name

Levo Sterile Cervical Drape w/Window

Version/Model Number

7894-1

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

5bd44cfc-7058-4f9a-aea1-be049388dc19

Public Version Date

June 13, 2022

Public Version Number

3

DI Record Publish Date

November 26, 2021

Package DI Number

10842430108843

Quantity per Package

6

Contains DI Package

00842430108846

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case