Catalog Number

-

Brand Name

Encompass

Version/Model Number

CD0478

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

-

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

KKX

Product Code Name

Drape, surgical

Public Device Record Key

0bb3f846-9f56-45c5-a7b0-deeeff6dc870

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

September 18, 2016

Package DI Number

50609953979309

Quantity per Package

12

Contains DI Package

00609953979304

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-