Catalog Number

400597

Brand Name

Regard™

Version/Model Number

NTRLEXMXL3-REG

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)

-

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

47590820-0571-426b-a517-9d52805a2a9e

Public Version Date

September 02, 2021

Public Version Number

1

DI Record Publish Date

August 25, 2021

Package DI Number

10326053117920

Quantity per Package

1000

Contains DI Package

00326053117923

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-