Catalog Number

-

Brand Name

Beacon

Version/Model Number

F-22-05

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K152586,K152586

Product Code

NEU

Product Code Name

MARKER, RADIOGRAPHIC, IMPLANTABLE

Public Device Record Key

57303053-5511-4ebd-99a5-0f7477b4598a

Public Version Date

March 03, 2022

Public Version Number

2

DI Record Publish Date

March 07, 2019

Package DI Number

10855208005176

Quantity per Package

5

Contains DI Package

00855208005179

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK