Catalog Number

-

Brand Name

HydroMark

Version/Model Number

4010-04-09-T4

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K130537,K130537

Product Code

NEU

Product Code Name

Marker, Radiographic, Implantable

Public Device Record Key

823bbb80-4f19-4af9-a5f1-755b28e69347

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

October 25, 2016

Package DI Number

10841911101571

Quantity per Package

10

Contains DI Package

00841911101574

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-