AccessGUDID - DEVICE: Grasper Tip, 12.5 (00852342007090)

GUDID

Device Identifier (DI) Information

Brand Name: Grasper Tip, 12.5
Version or Model: TIP002
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LEVITA MAGNETICS INTERNATIONAL CORPORATION

Primary DI Number: 00852342007090
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 066172261 *Terms of Use

Device Description: Grasper Tip, 12.5

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62415	Magnetic surgical manipulation system instrument, internal	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PNL	Magnetic Surgical System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ebff080c-f4fc-481f-8ff7-27c03c354148
Public Version Date: January 21, 2025
Public Version Number: 1
DI Record Publish Date: January 13, 2025