Catalog Number

516CS

Brand Name

Halo Systems

Version/Model Number

516CS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 2020

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

K040363

Product Code

LYT

Product Code Name

FIXATION ACCESSORY

Public Device Record Key

3121be37-f168-4d73-a4ff-afae3776dcd2

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

-