Catalog Number

-

Brand Name

Kirwan

Version/Model Number

15-1437AUS

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

-

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

K844823

Product Code

KNA

Product Code Name

Instrument, Manual, Specialized Obstetric-Gynecologic

Public Device Record Key

b563b79f-c558-44ca-895b-b0cecb435e67

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-