Catalog Number

HF-XXL

Brand Name

ORI

Version/Model Number

HF-XXL

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

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

K200977,K200977

Product Code

FYA

Product Code Name

Gown, Surgical

Public Device Record Key

63df5749-2a1f-40bd-ab09-890879da1cc4

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

January 28, 2021

Package DI Number

00854150007330

Quantity per Package

25

Contains DI Package

00854150007323

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE