AccessGUDID - DEVICE: MARS Scope Holder (00852342007076)

GUDID

Device Identifier (DI) Information

Brand Name: MARS Scope Holder
Version or Model: DRA002-04
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LEVITA MAGNETICS INTERNATIONAL CORPORATION

Primary DI Number: 00852342007076
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 066172261 *Terms of Use

Device Description: MARS Scope Holder

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:	No
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?
62417	Magnetic surgical manipulation system instrument, external, electric	A 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.	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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 1ff523f3-c54c-4832-8dd7-ff29d34362f0
Public Version Date: September 22, 2023
Public Version Number: 1
DI Record Publish Date: September 14, 2023