Catalog Number

-

Brand Name

AngioSystems SorbX

Version/Model Number

SX5100

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

824918f0-7e95-4ecc-ab83-e44506972dd8

Public Version Date

February 21, 2022

Public Version Number

2

DI Record Publish Date

April 19, 2021

Package DI Number

00816611025680

Quantity per Package

10

Contains DI Package

00816611025673

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-