Catalog Number

60004

Brand Name

FibermarX

Version/Model Number

60004

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K170026,K170026,K170026

Product Code

NEU

Product Code Name

Marker, Radiographic, Implantable

Public Device Record Key

1e1e5aad-c0b9-4ee8-8401-032ebdab1a23

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

January 18, 2018

Package DI Number

00850016008015

Quantity per Package

5

Contains DI Package

00850016008008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton