Catalog Number

-

Brand Name

E6561 Universal Light Handle Cover Standard

Version/Model Number

E6561

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

26ff824c-242f-41f9-ac38-8321c0f1b89f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 28, 2016

Package DI Number

00852205007250

Quantity per Package

250

Contains DI Package

00852205007243

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case