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On3-99d-2vm 120v

FDA UDI

Class II (US FDA UDI)

by Narishige Lifemed Co., Ltd.

Identity

Trade Name
ON3-99D-2VM 120V FDA UDI
Generic Name
Assisted reproduction electromechanical micromanipulator FDA UDI
Device Name
Assisted Reproduction Micromanipulators FDA UDI
Model / Reference
NAI-5 Manipulator Set FDA UDI
Description
Assisted Reproduction Micromanipulators FDA UDI

Identifiers

Primary DI / UDI-DI
04589818020074 FDA UDI
510(k) Number
K120877 FDA UDI
FDA Product Code
MQJ FDA UDI
GMDN Term
Assisted reproduction electromechanical micromanipulator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.6150 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Assisted reproduction electromechanical micromanipulator

On3-99d-2vm 120v by Narishige Lifemed Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Assisted reproduction electromechanical micromanipulator.

Cleared under the same submission

K120877 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Narishige Lifemed Co., Ltd.

Sources (1)

  • FDA UDI b9d109e5-65c6-4d27-8c55-2c2dc1dcd749 35 fields · synced May 31, 2026