Kitazato OPU Needle - KITAZATO CORPORATION

Duns Number:711091157

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More Product Details

Catalog Number

328000

Brand Name

Kitazato OPU Needle

Version/Model Number

328000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

MQE

Product Code Name

NEEDLE, ASSISTED REPRODUCTION

Device Record Status

Public Device Record Key

f217fd54-a8db-47e0-bcc7-1b1fd0e14c39

Public Version Date

October 05, 2022

Public Version Number

1

DI Record Publish Date

September 27, 2022

Additional Identifiers

Package DI Number

14580745041801

Quantity per Package

10

Contains DI Package

04580745041804

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"KITAZATO CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 177