Catalog Number

8888572552

Brand Name

Argyle

Version/Model Number

8888572552

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

GBS

Product Code Name

CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY

Public Device Record Key

a56e93be-1274-4eba-93e8-0c494f36735e

Public Version Date

March 08, 2022

Public Version Number

3

DI Record Publish Date

June 29, 2018

Package DI Number

30884521025466

Quantity per Package

10

Contains DI Package

20884521025469

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE