MMO-202NDVM - Assisted Reproduction Micromanipulator - NARISHIGE LIFEMED CO., LTD.

Duns Number:693293734

Device Description: Assisted Reproduction Micromanipulator

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More Product Details

Catalog Number

-

Brand Name

MMO-202NDVM

Version/Model Number

MMO-202NDVM Oil Hydraulic Micromanipulator

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

-

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

K002659

Product Code Details

Product Code

MQJ

Product Code Name

Micromanipulators And Microinjectors, Assisted Reproduction

Device Record Status

Public Device Record Key

f5b72df0-9dbd-443f-af52-fdd2a544f4ca

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NARISHIGE LIFEMED CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 30