Catalog Number

SMARK-M-SS3

Brand Name

SecurMark MRI

Version/Model Number

SMARK-M-SS3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K102608,K102608

Product Code

NEU

Product Code Name

MARKER, RADIOGRAPHIC, IMPLANTABLE

Public Device Record Key

6dd5ce91-e376-48db-ad7e-f6e5eaff31ae

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 04, 2015

Package DI Number

15420045503991

Quantity per Package

10

Contains DI Package

05420045503994

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX