Navigated Targeting Needle SPX1, Trocar Tip – 11G, 125mm

GUDID 03701311500414

ECENTIAL ROBOTICS

Bone access cannula
Primary Device ID03701311500414
NIH Device Record Keydad3d2df-e16a-446d-a045-8c851f246ffe
Commercial Distribution StatusIn Commercial Distribution
Brand NameNavigated Targeting Needle SPX1, Trocar Tip – 11G, 125mm
Version Model NumberA00028
Company DUNS261610964
Company NameECENTIAL ROBOTICS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com
Phone+33458005520
Emailservice@ecential-robotics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS103701311500414 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-09
Device Publish Date2023-03-01

Devices Manufactured by ECENTIAL ROBOTICS

03701311501374 - Patient Tracker SPX12023-12-25
03701311500940 - 3D Imaging Set SPX12023-09-14
03701311500704 - CoBot, Drill Bit2023-09-12
03701311500711 - CoBot, Drill Guide – Sleeve2023-09-12
03701311500728 - CoBot, Drill Guide – Cortical tip2023-09-12
03701311500735 - 3.5 mm Hex Head Screwdriver2023-09-12
03701311500742 - Fixation screw2023-09-12
03701311500759 - CoBot, Tool Holder2023-09-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.