Catalog Number

31368858

Brand Name

Argyle

Version/Model Number

31368858

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

FSD

Product Code Name

BINDER, ABDOMINAL

Public Device Record Key

853acd72-a4c5-471d-b1b5-40afb4bdc7a5

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 23, 2018

Package DI Number

10884527005642

Quantity per Package

100

Contains DI Package

20884527005649

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE