FDA.reportPublic FDA data

Toothed Grasper, Magnetic Surgical System

Primary DI
00852342007007
Brand
Toothed Grasper, Magnetic Surgical System
Company
LEVITA MAGNETICS INTERNATIONAL CORPORATION
Model
TGR001
Device description
Magnetic Surgical System Toothed Grasper,
Published
2016-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
00852342007007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852342007007008523420070078523420070070852342007007

GMDN Terms#

Term, Definition table
TermDefinition
Magnetic surgical manipulation system instrument, internalA sterile, invasive, magnetic device intended to be percutaneously inserted into the body to be used as a manoeuvrable object to permit transcutaneous grasping/manipulation/retraction of soft tissues/organs (e.g., gallbladder) during endoscopic/laparoscopic procedures, via magnetic coupling with an external magnetic device moved across the patient’s body surface by the operator. It is made of plastic and metal materials and may be in the form of a grasper, bent rod, or other shape designed to contact the target tissue/organ; dedicated tools to assist its insertion/retrieval are typically included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
066172261
Device count
1
Lot or batch
true
Expiration 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
00852342007014Magnetic Controller, Magnetic Surgical SystemMAG0012016-12-16
00852342007038MARS Surgeon Controlled ArmDRA0022023-09-14
00852342007076MARS Scope HolderDRA002-042023-09-14

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
00852342007014Magnetic Controller, Magnetic Surgical SystemLEVITA MAGNETICS INTERNATIONAL CORPORATIONPNL2016-12-16