Mitaka 3D Viewer - The 3D Viewer provides three-dimensional image - MITAKA KOHKI CO., LTD.

Duns Number:692666613

Device Description: The 3D Viewer provides three-dimensional image for endoscopic surgery.

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More Product Details

Catalog Number

-

Brand Name

Mitaka 3D Viewer

Version/Model Number

3DV

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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)

-

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

EPT

Product Code Name

Microscope, Surgical

Device Record Status

Public Device Record Key

c2612ac0-565d-4222-98c9-03e2625c2987

Public Version Date

March 11, 2019

Public Version Number

2

DI Record Publish Date

August 01, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MITAKA KOHKI CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 9