Catalog Number

-

Brand Name

E6340 Probe Cover, PE, Gel and Elastic bands 23x61cm - 9"x24"

Version/Model Number

E6340

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

b0109300-acdc-4152-87f7-c741fdf14c49

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 21, 2016

Package DI Number

00816953028240

Quantity per Package

20

Contains DI Package

00816953028233

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Case