Catalog Number

1022

Brand Name

Argyle

Version/Model Number

1022

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K083042,K083042

Product Code

FRO

Product Code Name

Dressing, wound, drug

Public Device Record Key

3e8e432d-77a9-4243-92ec-d3d6596f8203

Public Version Date

May 23, 2019

Public Version Number

3

DI Record Publish Date

June 29, 2018

Package DI Number

10884527000326

Quantity per Package

48

Contains DI Package

10884521537439

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE