Catalog Number

32-1721

Brand Name

DeRoyal

Version/Model Number

32-1721

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)

-

Over the Counter (OTC)

Yes

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

d1723323-0962-41fe-9d3a-e30351565504

Public Version Date

July 08, 2021

Public Version Number

1

DI Record Publish Date

June 30, 2021

Package DI Number

30749756589230

Quantity per Package

3

Contains DI Package

00749756589239

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box