Catalog Number

-

Brand Name

PolyMark™

Version/Model Number

PM-1.0-5-18-20

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K102506

Product Code

NEU

Product Code Name

Marker, Radiographic, Implantable

Public Device Record Key

7f490e5f-369b-48da-99ec-e5472e2099b8

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

August 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-