Catalog Number

DDS-N192-20

Brand Name

AuraGuard

Version/Model Number

DDS-N192-20

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)

-

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

0fd2b0e8-6d13-44d8-b969-6ba1beba3ed7

Public Version Date

March 25, 2022

Public Version Number

1

DI Record Publish Date

March 17, 2022

Package DI Number

00858711006282

Quantity per Package

10

Contains DI Package

00858711006275

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case