Catalog Number

23-005

Brand Name

DeRoyal

Version/Model Number

23-005

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

94c53e82-db00-434a-b264-cc5ed6f4ee72

Public Version Date

July 07, 2021

Public Version Number

1

DI Record Publish Date

June 29, 2021

Package DI Number

50749756303403

Quantity per Package

50

Contains DI Package

00749756303408

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case