Catalog Number

349001

Brand Name

Kitazato OPU Reduced Needle, Type3-v4

Version/Model Number

349001 Type3-v4

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

6d916757-08ca-4806-9617-a39a98033688

Public Version Date

March 29, 2021

Public Version Number

5

DI Record Publish Date

May 30, 2018

Package DI Number

14580303269296

Quantity per Package

10

Contains DI Package

04580303269299

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-