CorPath 200 Cassette - Corindus, Inc.

Duns Number:781746586

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More Product Details

Catalog Number

160-00173-NC

Brand Name

CorPath 200 Cassette

Version/Model Number

160-00173-NC

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 06, 2019

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)

Yes

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

DXX

Product Code Name

System, Catheter Control, Steerable

Device Record Status

Public Device Record Key

f72f3762-102a-490c-a8c7-b8c296b59101

Public Version Date

October 19, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CORINDUS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 9