FDA.reportPublic FDA data

Grasper Tip, 12.5

Primary DI
10852342007097
Brand
Grasper Tip, 12.5
Company
LEVITA MAGNETICS INTERNATIONAL CORPORATION
Model
TIP002
Device description
Grasper Tip, 12.5
Published
2025-01-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852342007097PackageGS16In Commercial Distribution
00852342007090PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085234200709710852342007097
00852342007090008523420070908523420070900852342007090

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852342007090Grasper 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
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
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
00852342007007Toothed Grasper, Magnetic Surgical SystemLEVITA MAGNETICS INTERNATIONAL CORPORATIONPNL2016-10-18