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Magnetic Controller, Magnetic Surgical System

FDA UDI

Class II (US FDA UDI)

by Levita Magnetics International Corp.

Identity

Trade Name
Magnetic Controller, Magnetic Surgical System FDA UDI
Generic Name
Magnetic surgical manipulation system instrument, external, permanent magnet FDA UDI
Device Name
Magnetic Controller, Magnetic Surgical System FDA UDI
Model / Reference
MAG001 FDA UDI
Description
Magnetic Controller, Magnetic Surgical System FDA UDI

Identifiers

Primary DI / UDI-DI
00852342007014 FDA UDI
510(k) Number
DEN150007 FDA UDI
FDA Product Code
PNL FDA UDI
GMDN Term
Magnetic surgical manipulation system instrument, external, permanent magnet FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4815 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

Yes

FDA UDI

Category: Magnetic surgical manipulation system instrument, external, permanent magnet

Magnetic Controller, Magnetic Surgical System by Levita Magnetics International Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Magnetic surgical manipulation system instrument, external, permanent magnet.

Cleared under the same submission

DEN150007 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Levita Magnetics International Corp.

Sources (1)

  • FDA UDI 37825990-b0b8-4ab0-bdeb-7a89ad3cba3d 34 fields · synced May 30, 2026