Catalog Number

-

Brand Name

Nova 10 Fiducial Marker

Version/Model Number

F-01-03-0115

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 27, 2022

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

K192771

Product Code

NEU

Product Code Name

Marker, Radiographic, Implantable

Public Device Record Key

090abe6e-11c2-43fa-bec5-9359489f6b10

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

April 25, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-