AccessGUDID - DEVICE: iSR'obot Mona Lisa (08885014610382)

GUDID

Device Identifier (DI) Information

Brand Name: iSR'obot Mona Lisa
Version or Model: iSR'obot Mona Lisa 2.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOBOT SURGICAL PTE. LTD.

Primary DI Number: 08885014610382
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 595137775 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	No
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?
66831	Prostate stereotactic biopsy/ablation system	An assembly of electrically-powered devices intended to be used for trajectory planning and positioning of interventional instruments during computer-assisted transperineal prostate biopsy and ablation procedures under image-guidance, using real-time ultrasound imaging and pre-acquired MRI scans. It consists of a software-assisted console with a screen interface and a robotic electromechanical arm designed to guide the surgical instrument (e.g., prostate needle) to the target site following the pre-planned path set by the physician.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYO	System, Imaging, Pulsed Echo, Ultrasonic
ITX	Transducer, Ultrasonic, Diagnostic
LLZ	System, Image Processing, Radiological
OIJ	Biopsy Needle Guide Kit

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: 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: c40a5a4a-99f7-4f25-ba42-dfbff33b3671
Public Version Date: June 14, 2024
Public Version Number: 2
DI Record Publish Date: February 29, 2024