Catalog Number

X-4564

Brand Name

DEKNATEL

Version/Model Number

IPN026883

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

DXZ

Product Code Name

PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Public Device Record Key

f7f8708f-a3bb-4a9a-a2d2-f35fcb5e8852

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

October 16, 2015

Package DI Number

24026704426700

Quantity per Package

1

Contains DI Package

04026704426706

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Sleeve