Catalog Number

515C4

Brand Name

Halo Systems

Version/Model Number

515C4

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 2020

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

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

K051918

Product Code

HAX

Product Code Name

TONG, SKULL FOR TRACTION

Public Device Record Key

12ac2a0c-7986-47ad-866f-4930229c1170

Public Version Date

July 22, 2020

Public Version Number

3

DI Record Publish Date

May 16, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-