Catalog Number

RCK40

Brand Name

PerfectCut Aortotomy System

Version/Model Number

RCK40

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DWS

Product Code Name

Instruments, Surgical, Cardiovascular

Public Device Record Key

f84610b1-5e29-434a-928f-9dc372d31ee0

Public Version Date

October 18, 2019

Public Version Number

1

DI Record Publish Date

October 10, 2019

Package DI Number

20634624344000

Quantity per Package

6

Contains DI Package

10634624344003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-