FDA.reportPublic FDA data

Scope Cup

Primary DI
00852342007137
Brand
Scope Cup
Company
LEVITA MAGNETICS INTERNATIONAL CORPORATION
Model
DRA002-06
Device description
Scope Cup, MARS
Published
2025-01-13
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852342007137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852342007137008523420071378523420071370852342007137

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic surgical manipulation system instrument, external, electricA noninvasive, mains electricity (AC-powered), hand-held electromagnetic 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 is made of metal and plastic materials and is in the form of a gliding pad. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
066172261
Device count
1
Serial number
true
Sterilization required before use
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
00852342007014Magnetic Controller, Magnetic Surgical SystemMAG0012016-12-16
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
00852342007038MARS Surgeon Controlled ArmLEVITA MAGNETICS INTERNATIONAL CORPORATIONPNL2023-09-14
00852342007076MARS Scope HolderLEVITA MAGNETICS INTERNATIONAL CORPORATIONPNL2023-09-14
00852342007014Magnetic Controller, Magnetic Surgical SystemLEVITA MAGNETICS INTERNATIONAL CORPORATIONPNL2016-12-16
00852342007007Toothed Grasper, Magnetic Surgical SystemLEVITA MAGNETICS INTERNATIONAL CORPORATIONPNL2016-10-18