Catalog Number

E6505

Brand Name

E6505 Bronchoscope Drape

Version/Model Number

E6505

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

4547cc25-c570-42e7-bd7e-2ac87d577f08

Public Version Date

April 22, 2020

Public Version Number

3

DI Record Publish Date

November 27, 2016

Package DI Number

00816953029414

Quantity per Package

100

Contains DI Package

00816953029407

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case