Catalog Number

-

Brand Name

Aortotomy System Lancet 3.3mm

Version/Model Number

ALX33

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

230794e2-2ad1-4763-bef6-3fca9dfeb98b

Public Version Date

January 22, 2021

Public Version Number

3

DI Record Publish Date

October 10, 2019

Package DI Number

20634624175338

Quantity per Package

25

Contains DI Package

00634624175334

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-