Toothed Grasper, Magnetic Surgical System

GUDID 00852342007007

Magnetic Surgical System Toothed Grasper,

LEVITA MAGNETICS INTERNATIONAL CORPORATION

Magnetic surgical manipulation system instrument, internal
Primary Device ID00852342007007
NIH Device Record Keyc60657f5-29b6-48e3-a27d-b8aef40f58f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameToothed Grasper, Magnetic Surgical System
Version Model NumberTGR001
Company DUNS066172261
Company NameLEVITA MAGNETICS INTERNATIONAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100852342007007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PNLMagnetic Surgical System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-18

Devices Manufactured by LEVITA MAGNETICS INTERNATIONAL CORPORATION

00852342007038 - MARS Surgeon Controlled Arm2023-09-22 MARS Surgeon Controlled Arm
00852342007076 - MARS Scope Holder2023-09-22 MARS Scope Holder
00852342007007 - Toothed Grasper, Magnetic Surgical System2018-07-06Magnetic Surgical System Toothed Grasper,
00852342007007 - Toothed Grasper, Magnetic Surgical System2018-07-06 Magnetic Surgical System Toothed Grasper,
00852342007014 - Magnetic Controller, Magnetic Surgical System2018-07-06 Magnetic Controller, Magnetic Surgical System

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