Catalog Number

-

Brand Name

AngioSystems SorbX

Version/Model Number

SX8120

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KPY

Product Code Name

Shield, Protective, Personnel

Public Device Record Key

1e6989fc-3fbd-43e6-8cf6-d960db2eabf9

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 05, 2018

Package DI Number

00816611022405

Quantity per Package

15

Contains DI Package

00816611022399

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-