Catalog Number

461008

Brand Name

Argyle

Version/Model Number

461008

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

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Public Device Record Key

b024176c-37d0-426e-96a8-a618d9e2c5a8

Public Version Date

October 12, 2020

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

10884521067363

Quantity per Package

50

Contains DI Package

20884521067360

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE