Catalog Number

-

Brand Name

Anjon Bremer Halo System

Version/Model Number

Molded Halo Crown - Sterile

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

-

Product Code

JEC

Product Code Name

Component, Traction, Invasive

Public Device Record Key

ede454fc-5516-4305-9639-f063371c3d5a

Public Version Date

April 08, 2020

Public Version Number

1

DI Record Publish Date

March 31, 2020

Package DI Number

10810592030630

Quantity per Package

3

Contains DI Package

00810592030633

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

3-UNIT SHIPPER