Catalog Number

V77-301371

Brand Name

DeRoyal

Version/Model Number

V77-301371

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

817f2c9c-9a1a-45ed-b2bb-00a766171add

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

July 28, 2021

Package DI Number

50749756297696

Quantity per Package

20

Contains DI Package

00749756297691

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case