Catalog Number

23-004

Brand Name

DeRoyal

Version/Model Number

23-004

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LYU

Product Code Name

ACCESSORY, SURGICAL APPAREL

Public Device Record Key

815d1f5b-44ad-4101-8866-4f6ce551801d

Public Version Date

July 07, 2021

Public Version Number

1

DI Record Publish Date

June 29, 2021

Package DI Number

50749756303397

Quantity per Package

50

Contains DI Package

00749756303392

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case