Catalog Number

-

Brand Name

Halo®

Version/Model Number

HAL100S

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

152fc880-f909-4898-b4ce-1d4b311de3c4

Public Version Date

March 17, 2022

Public Version Number

2

DI Record Publish Date

April 15, 2021

Package DI Number

00649531210122

Quantity per Package

10

Contains DI Package

00649531200123

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case