Catalog Number

-

Brand Name

DeRoyal

Version/Model Number

NP-ST0450

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KDQ

Product Code Name

BOTTLE, COLLECTION, VACUUM

Public Device Record Key

714dc86d-4cb0-4e15-828a-73622100ccc0

Public Version Date

January 08, 2021

Public Version Number

6

DI Record Publish Date

April 18, 2017

Package DI Number

50749756927012

Quantity per Package

10

Contains DI Package

00749756927017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case