Catalog Number

-

Brand Name

N/A

Version/Model Number

DMTS

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

MZY

Product Code Name

Graft, Vascular, Stainless Steel Tunneler

Public Device Record Key

fe018129-9789-4d11-bace-2e9aee6580d1

Public Version Date

September 05, 2019

Public Version Number

1

DI Record Publish Date

August 28, 2019

Package DI Number

50884908144715

Quantity per Package

10

Contains DI Package

00884908144710

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX