Catalog Number

611051

Brand Name

Z-6™

Version/Model Number

611051

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

K211910

Product Code

DXF

Product Code Name

CATHETER, SEPTOSTOMY

Public Device Record Key

9bf4ec84-0dab-406e-b034-0d0152856e36

Public Version Date

September 13, 2021

Public Version Number

1

DI Record Publish Date

September 04, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-