Catalog Number

329000

Brand Name

Kitazato OPU Needle

Version/Model Number

329000

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

53b988f7-4bf2-4994-9b11-9943f7e6a09b

Public Version Date

October 05, 2022

Public Version Number

1

DI Record Publish Date

September 27, 2022

Package DI Number

14580745041818

Quantity per Package

10

Contains DI Package

04580745041811

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-