Catalog Number

30-810

Brand Name

DeRoyal

Version/Model Number

30-810

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

2b5d7497-721a-437d-8494-63347105d4ce

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

June 30, 2021

Package DI Number

30749756554221

Quantity per Package

10

Contains DI Package

00749756554220

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box