iSR'obot Biopsy Kit G4AA610

GUDID 08885014610023

BIOBOT SURGICAL PTE. LTD.

Needle guide, single-use
Primary Device ID08885014610023
NIH Device Record Keyf6cfd6bd-8b66-483a-acfe-074a86d56c83
Commercial Distribution StatusIn Commercial Distribution
Brand NameiSR'obot Biopsy Kit
Version Model NumberiSR'obot Biopsy Kit
Catalog NumberG4AA610
Company DUNS595137775
Company NameBIOBOT SURGICAL PTE. LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108885014610023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OIJBiopsy Needle Guide Kit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-24
Device Publish Date2024-06-14