Catalog Number

-

Brand Name

AngioSystems SorbX

Version/Model Number

SX8300

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 30, 2050

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

004b4528-56f5-4d40-8f34-8d63d4db9ecb

Public Version Date

February 21, 2022

Public Version Number

2

DI Record Publish Date

December 09, 2021

Package DI Number

00816611025734

Quantity per Package

15

Contains DI Package

00816611025727

Package Discontinue Date

December 30, 2050

Package Status

In Commercial Distribution

Package Type

-