Catalog Number

-

Brand Name

LOCalizer

Version/Model Number

HB200

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 21, 2017

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

PBY

Product Code Name

Temporary Tissue Marker

Public Device Record Key

cd69305d-c0b2-44c3-8064-bbdccfbd6a01

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

June 16, 2017

Package DI Number

10855436007027

Quantity per Package

10

Contains DI Package

00855436007020

Package Discontinue Date

December 21, 2017

Package Status

Not in Commercial Distribution

Package Type

Box