Catalog Number

327001

Brand Name

Kitazato OPU Needle with Connection Tube, Type2-v11

Version/Model Number

327001 Type2-v11

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

MQE

Product Code Name

NEEDLE, ASSISTED REPRODUCTION

Public Device Record Key

bcbd2c0e-209e-4561-b74a-5c2c5314947e

Public Version Date

March 29, 2021

Public Version Number

3

DI Record Publish Date

June 01, 2019

Package DI Number

14580303269814

Quantity per Package

10

Contains DI Package

04580303269817

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-