Catalog Number

8888531038

Brand Name

Argyle

Version/Model Number

8888531038

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

GEA

Product Code Name

CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Public Device Record Key

fa1c9105-6a12-412a-8a2f-82a805ba1136

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 30, 2018

Package DI Number

00884521071882

Quantity per Package

10

Contains DI Package

00884521029012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE