Catalog Number

382302

Brand Name

Kitazato OPU Two-Stage Reduced Needle, Type4-v2

Version/Model Number

382302 Type4-v2

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

5b7f88de-7488-477d-8c78-271bb62ffb8c

Public Version Date

March 29, 2021

Public Version Number

4

DI Record Publish Date

May 30, 2018

Package DI Number

14580303269357

Quantity per Package

10

Contains DI Package

04580303269350

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-