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Mitaka 3D Viewer

FDA UDI

Class I (US FDA UDI)

by Mitaka Kohki Co., Ltd.

Identity

Trade Name
Mitaka 3D Viewer FDA UDI
Generic Name
Surgical instrument assist arm system, power-adjusted FDA UDI
Device Name
The 3D Viewer provides three-dimensional image for endoscopic surgery. FDA UDI
Model / Reference
3DV FDA UDI
Description
The 3D Viewer provides three-dimensional image for endoscopic surgery. FDA UDI

Identifiers

Primary DI / UDI-DI
04589698450220 FDA UDI
FDA Product Code
EPT FDA UDI
GMDN Term
Surgical instrument assist arm system, power-adjusted FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4700 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Chlorine Dioxide FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Surgical instrument assist arm system, power-adjusted

Mitaka 3D Viewer by Mitaka Kohki Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument assist arm system, power-adjusted.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mitaka Kohki Co., Ltd.

Sources (1)

  • FDA UDI c2612ac0-565d-4222-98c9-03e2625c2987 33 fields · synced Jun 1, 2026