Catalog Number

-

Brand Name

E6534 Isolation Transport Bag 51x51cm -18x18,5"

Version/Model Number

E6534

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

0f6f3244-ec87-4556-a95d-efab99874d7f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 28, 2016

Package DI Number

00816953029919

Quantity per Package

72

Contains DI Package

00816953029902

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case