Catalog Number

-

Brand Name

Kirwan

Version/Model Number

40-3601

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"

Yes

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

K070360,K070360

Product Code

LFL

Product Code Name

Instrument, Ultrasonic Surgical

Public Device Record Key

46aba8c6-aa83-4c90-b458-115790400012

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 11, 2016

Package DI Number

10841019107734

Quantity per Package

5

Contains DI Package

00841019107737

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-