Catalog Number

-

Brand Name

Encompass

Version/Model Number

26188-012

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

FRG

Product Code Name

Wrap, sterilization

Public Device Record Key

0d528c9e-7291-4079-86d0-5a1bea3af03a

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

50609953600937

Quantity per Package

36

Contains DI Package

00609953600932

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-