Catalog Number

-

Brand Name

Halo®

Version/Model Number

HAL100M

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

5d7577a5-23a1-4a63-a4b2-8cb20ec0330d

Public Version Date

March 17, 2022

Public Version Number

2

DI Record Publish Date

April 16, 2021

Package DI Number

00649531210146

Quantity per Package

10

Contains DI Package

00649531200147

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case