Catalog Number

8888565036

Brand Name

Argyle

Version/Model Number

8888565036

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)

Yes

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

DRC

Product Code Name

Trocar

Public Device Record Key

1fb8d7e6-f3ae-44b7-ba9a-d14706e9e241

Public Version Date

February 15, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

20884521025414

Quantity per Package

10

Contains DI Package

10884521025417

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE