Catalog Number

-

Brand Name

ROTAPRO™

Version/Model Number

H7493930901R0

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

-

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

P900056,P900056

Product Code

MCX

Product Code Name

CATHETER, CORONARY, ATHERECTOMY

Public Device Record Key

3270ce3d-9b29-4203-8fa8-e6ee488babc1

Public Version Date

April 06, 2021

Public Version Number

3

DI Record Publish Date

July 11, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-