Catalog Number

25-0701NS

Brand Name

DeRoyal

Version/Model Number

25-0701NS

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

9b1a5941-f748-4a64-a027-a4e614792229

Public Version Date

July 07, 2021

Public Version Number

1

DI Record Publish Date

June 29, 2021

Package DI Number

50749756255771

Quantity per Package

100

Contains DI Package

00749756255776

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case