Catalog Number

6720540E

Brand Name

ADROIT

Version/Model Number

6720540E

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

DQY

Product Code Name

CATHETER, PERCUTANEOUS

Public Device Record Key

d1eca3c8-bd13-497e-b6f0-cb413692161e

Public Version Date

September 14, 2022

Public Version Number

10

DI Record Publish Date

September 28, 2017

Package DI Number

20705032071748

Quantity per Package

5

Contains DI Package

10705032071741

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX