Catalog Number

RCK45

Brand Name

PerfectCut Aortotomy System

Version/Model Number

RCK45

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

ac0f46eb-ec44-40cc-a0b6-cc75adcb9436

Public Version Date

October 18, 2019

Public Version Number

1

DI Record Publish Date

October 10, 2019

Package DI Number

20634624344505

Quantity per Package

6

Contains DI Package

10634624344508

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-