GUDID 08885014610382

BIOBOT SURGICAL PTE. LTD.

Prostate stereotactic biopsy/ablation system
Primary Device ID08885014610382
NIH Device Record Keyc40a5a4a-99f7-4f25-ba42-dfbff33b3671
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberiSR'obot Mona Lisa 2.0
Company DUNS595137775
Company NameBIOBOT SURGICAL PTE. LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108885014610382 [Primary]

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-08
Device Publish Date2024-02-29

Devices Manufactured by BIOBOT SURGICAL PTE. LTD.

08885014610023 - iSR'obot Biopsy Kit2024-06-24
08885014610184 - iSR'obot Kit2024-06-24
08885014610207 - iSR'obot Kit2024-06-24
08885014610221 - iSR'obot Kit2024-06-24
08885014610245 - NA2024-03-08
08885014610382 - NA2024-03-08
08885014610382 - NA2024-03-08

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