iSR'obot Kit AS-00006415

GUDID 08885014610221

BIOBOT SURGICAL PTE. LTD.

Needle guide, single-use
Primary Device ID08885014610221
NIH Device Record Key9245b5e1-f0a9-44eb-ad87-2f9eec997fc5
Commercial Distribution StatusIn Commercial Distribution
Brand NameiSR'obot Kit
Version Model NumberiSR'obot Kit - 17G
Catalog NumberAS-00006415
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
GS108885014610221 [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