Catalog Number

100053

Brand Name

Anjon Bremer Halo System

Version/Model Number

Mayfield Adaptor Set Ant/Post - Molded Crown

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

-

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

95709895-e40e-4f77-a825-83f578f7cb36

Public Version Date

April 09, 2020

Public Version Number

1

DI Record Publish Date

April 01, 2020

Package DI Number

10810592030586

Quantity per Package

3

Contains DI Package

00810592030589

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

3 BOX SHIPPER