Catalog Number

25-012NS

Brand Name

DeRoyal

Version/Model Number

25-012NS

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

KDC

Product Code Name

INSTRUMENT, SURGICAL, DISPOSABLE

Public Device Record Key

df5054b0-b5a3-4d13-b2bd-34df9b4e9a95

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

June 29, 2021

Package DI Number

50749756805471

Quantity per Package

200

Contains DI Package

00749756805476

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case