Catalog Number

-

Brand Name

Encompass

Version/Model Number

46712-217

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

FYA

Product Code Name

GOWN, SURGICAL

Public Device Record Key

f80002d0-2fae-42db-bb95-b9a4f01302e2

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

50609953472589

Quantity per Package

12

Contains DI Package

00609953472584

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-