Catalog Number

-

Brand Name

Encompass

Version/Model Number

46721-217

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

e6526fe8-e0a5-4dd1-81d0-76442c464253

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

50609953915574

Quantity per Package

12

Contains DI Package

00609953915579

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-