Catalog Number

816-055080-150U

Brand Name

Castor NC PTA Balloon Dilatation Catheter

Version/Model Number

rev 01

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

LIT

Product Code Name

Catheter, Angioplasty, Peripheral, Transluminal

Public Device Record Key

9728b3f4-c406-4e1c-b360-cd4a52fb10f8

Public Version Date

December 06, 2021

Public Version Number

5

DI Record Publish Date

June 30, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-