Catalog Number

400P10

Brand Name

DeRoyal

Version/Model Number

400P10

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

IKX

Product Code Name

AID, TRANSFER

Public Device Record Key

d7fef0eb-6d84-4ccb-962a-3e8f612ee114

Public Version Date

August 02, 2021

Public Version Number

1

DI Record Publish Date

July 23, 2021

Package DI Number

50749756797905

Quantity per Package

25

Contains DI Package

00749756797900

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case