Catalog Number

-

Brand Name

Tumark Sphera

Version/Model Number

351270

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

NEU

Product Code Name

Marker, Radiographic, Implantable

Public Device Record Key

38ba28c7-328d-4ae5-a657-80b9040dfda4

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

October 08, 2021

Package DI Number

14250195611809

Quantity per Package

10

Contains DI Package

04250195611802

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-