AngioSystems SorbX - ANGIOSYSTEMS, INCORPORATED

Duns Number:144884467

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More Product Details

Catalog Number

-

Brand Name

AngioSystems SorbX

Version/Model Number

SX8232

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

KPY

Product Code Name

Shield, Protective, Personnel

Device Record Status

Public Device Record Key

1cf5d20d-676c-4542-a426-86e76344edfa

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 05, 2018

Additional Identifiers

Package DI Number

00816611022719

Quantity per Package

15

Contains DI Package

00816611022702

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"ANGIOSYSTEMS, INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 170
2 A medical device with a moderate to high risk that requires special controls. 88
U Unclassified 1