ZILIENT - 4gram tip, short taper, .018" diameter 195cm - Cardiovascular Systems, Inc.

Duns Number:024954518

Device Description: 4gram tip, short taper, .018" diameter 195cm

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More Product Details

Catalog Number

7-10049-03

Brand Name

ZILIENT

Version/Model Number

04G-195-018

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)

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

MCW

Product Code Name

Catheter, Peripheral, Atherectomy

Device Record Status

Public Device Record Key

f2b8b914-7bef-4120-98cd-e586ec426d56

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

March 02, 2018

Additional Identifiers

Package DI Number

30852528005477

Quantity per Package

5

Contains DI Package

10852528005473

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"CARDIOVASCULAR SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 123
3 A medical device with high risk that requires premarket approval 15