Catalog Number

HAL510F

Brand Name

Halo One™ Thin-Walled Guiding Sheath

Version/Model Number

HAL510F

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 18, 2017

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

-

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

97e1d94b-6dc0-4b87-8b1c-42ad1244f9bd

Public Version Date

December 22, 2021

Public Version Number

8

DI Record Publish Date

June 10, 2016

Package DI Number

10801741129695

Quantity per Package

5

Contains DI Package

00801741129698

Package Discontinue Date

January 18, 2017

Package Status

Not in Commercial Distribution

Package Type

CA