Catalog Number

350304

Brand Name

Kitazato OPU Needle Type2-v5

Version/Model Number

350304 Type2-v5

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

77581073-1cd5-410b-919f-f957c57d8e1d

Public Version Date

March 29, 2021

Public Version Number

5

DI Record Publish Date

November 09, 2016

Package DI Number

14580303269128

Quantity per Package

10

Contains DI Package

04580303269121

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-