Catalog Number

-

Brand Name

LOCalizer

Version/Model Number

HB300-10

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"

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

43ac9638-36c2-458f-b20a-5815c20793b7

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

February 23, 2020

Package DI Number

10855436007126

Quantity per Package

10

Contains DI Package

00855436007129

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton