Catalog Number

-

Brand Name

Skytron Argos

Version/Model Number

B5-010-02-1

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

-

Product Code

PUI

Product Code Name

Drape, Surgical, Exempt

Public Device Record Key

9242f82d-06a2-4f20-b169-7b025c5c1aae

Public Version Date

August 16, 2022

Public Version Number

1

DI Record Publish Date

August 08, 2022

Package DI Number

30748426118572

Quantity per Package

25

Contains DI Package

00748426118571

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-