Catalog Number

MI30000

Brand Name

Argyle

Version/Model Number

MI30000

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

KGX

Product Code Name

Tape and bandage, adhesive

Public Device Record Key

a8d56a64-1a42-44c2-b2e7-861e223318d8

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

June 30, 2018

Package DI Number

10884527005291

Quantity per Package

50

Contains DI Package

20884527005298

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE