Catalog Number

381722

Brand Name

Kitazato OPU Needle

Version/Model Number

381722

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

6227d388-b45d-476e-addc-64793a573dce

Public Version Date

October 05, 2022

Public Version Number

1

DI Record Publish Date

September 27, 2022

Package DI Number

14580745041481

Quantity per Package

10

Contains DI Package

04580745041484

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-