Catalog Number

100005

Brand Name

Anjon Bremer Halo System

Version/Model Number

Classic Vest, Small (176cm and shorter), 32-38 in. (82-98cm)

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

K171863

Product Code

JEC

Product Code Name

Component, Traction, Invasive

Public Device Record Key

50857584-f1c0-4d7a-b46b-7fecf58e2538

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

April 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-