Catalog Number

8881443009-

Brand Name

Argyle

Version/Model Number

8881443009

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

EHZ

Product Code Name

Evacuator, oral cavity

Public Device Record Key

0a386353-8888-4734-90e7-245388488e6c

Public Version Date

May 26, 2022

Public Version Number

1

DI Record Publish Date

May 18, 2022

Package DI Number

50192253021798

Quantity per Package

5

Contains DI Package

20192253021797

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE