Catalog Number

77-400113

Brand Name

DeRoyal

Version/Model Number

77-400113

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

MDM

Product Code Name

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Public Device Record Key

666ddd59-2944-44d0-9f5a-ef49acf88414

Public Version Date

August 05, 2021

Public Version Number

1

DI Record Publish Date

July 28, 2021

Package DI Number

50749756324170

Quantity per Package

50

Contains DI Package

00749756324175

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case