Catalog Number

2101

Brand Name

Argyle

Version/Model Number

2101

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

Yes

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

-

FDA Premarket Submission

-

Product Code

FCM

Product Code Name

Tray, catheterization, sterile urethral, with or without catheter (kit)

Public Device Record Key

9d439b54-9578-4667-a14a-5473a7d2ab55

Public Version Date

February 23, 2021

Public Version Number

6

DI Record Publish Date

May 19, 2017

Package DI Number

00884521073312

Quantity per Package

100

Contains DI Package

00884521146740

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE