Catalog Number

326001

Brand Name

Kitazato OPU Needle with Connection Tube, Type2-v10

Version/Model Number

326001 Type2-v10

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

64c7fd0a-b097-439e-a8fb-96b96174f2c2

Public Version Date

March 29, 2021

Public Version Number

3

DI Record Publish Date

June 01, 2019

Package DI Number

14580303269807

Quantity per Package

10

Contains DI Package

04580303269800

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-