Catalog Number

HAL545

Brand Name

Halo One™ Thin-Walled Guiding Sheath

Version/Model Number

HAL545

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"

Yes

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

K161183

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

8a60a508-a0d8-4147-9583-158d08be0704

Public Version Date

December 22, 2021

Public Version Number

7

DI Record Publish Date

June 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-