FDA.reportPublic FDA data

Magnetic Controller, Magnetic Surgical System

Primary DI
00852342007014
Brand
Magnetic Controller, Magnetic Surgical System
Company
LEVITA MAGNETICS INTERNATIONAL CORPORATION
Model
MAG001
Device description
Magnetic Controller, Magnetic Surgical System
Published
2016-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PNLMagnetic Surgical System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNLMagnetic Surgical SystemGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN150007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN150007000Magnetic Surgical SystemLevita Magnetics International Corp2016-06-13PNL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852342007014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852342007014008523420070148523420070140852342007014

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic surgical manipulation system instrument, external, permanentA noninvasive, hand-held, magnetic surgical device intended to be moved across a patient’s body surface to magnetically couple with and control the manoeuvring of an invasive instrument percutaneously inserted into the body, to permit transcutaneous grasping/manipulation/retraction of soft tissues/organs (e.g., gallbladder) during endoscopic/laparoscopic procedures. It includes a permanent magnet and is made of metal and plastic materials in the form of a gliding pad. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
066172261
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852342007090Grasper Tip, 12.5TIP0022025-01-13
10852342007097Grasper Tip, 12.5TIP0022025-01-13
00852342007106Scope Adapter, 10mmDRA002-052025-01-13
00852342007137Scope CupDRA002-062025-01-13
00852342007038MARS Surgeon Controlled ArmDRA0022023-09-14
00852342007076MARS Scope HolderDRA002-042023-09-14
00852342007007Toothed Grasper, Magnetic Surgical SystemTGR0012016-10-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852342007090Grasper Tip, 12.5LEVITA MAGNETICS INTERNATIONAL CORPORATIONPNL2025-01-13
10852342007097Grasper Tip, 12.5LEVITA MAGNETICS INTERNATIONAL CORPORATIONPNL2025-01-13
00852342007106Scope Adapter, 10mmLEVITA MAGNETICS INTERNATIONAL CORPORATIONPNL2025-01-13
00852342007137Scope CupLEVITA MAGNETICS INTERNATIONAL CORPORATIONPNL2025-01-13
00852342007038MARS Surgeon Controlled ArmLEVITA MAGNETICS INTERNATIONAL CORPORATIONPNL2023-09-14
00852342007076MARS Scope HolderLEVITA MAGNETICS INTERNATIONAL CORPORATIONPNL2023-09-14
00852342007007Toothed Grasper, Magnetic Surgical SystemLEVITA MAGNETICS INTERNATIONAL CORPORATIONPNL2016-10-18