Catalog Number

D015-008-2U

Brand Name

EZ Stent

Version/Model Number

D015-008-2U

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"

-

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

NDP

Product Code Name

Accessories, Implant, Dental, Endosseous

Public Device Record Key

8e24795e-7a89-4edd-a649-84a4da0a1dd9

Public Version Date

March 23, 2022

Public Version Number

1

DI Record Publish Date

March 15, 2022

Package DI Number

20814639023026

Quantity per Package

200

Contains DI Package

00814639023022

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton