ELEMENTS LEAD LOCALIZATION 26338-02

GUDID 04056481006884

Brainlab AG

Robotic surgical navigation system
Primary Device ID04056481006884
NIH Device Record Keye35be622-74ca-45a7-99e0-2ee4a7120f3e
Commercial Distribution StatusIn Commercial Distribution
Brand NameELEMENTS LEAD LOCALIZATION
Version Model Number1.0
Catalog Number26338-02
Company DUNS314482980
Company NameBrainlab AG
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49899915680
Emailcontact@brainlab.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481006884 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-18

Devices Manufactured by Brainlab AG

04056481140809 - Curve 1.2 Dual Navigation Station2025-03-26
04056481141677 - Cirq Robotic Disposable Kinematic Unit2025-03-26
04056481125967 - Patient Mask Set 2025-03-18
04056481142698 - Frameless SRS MASK SET CRANIAL2025-03-18
04056481142704 - Frameless SRS MASK SET EXTENDED 2025-03-18
04056481145620 - Alignment Reduction Tube Cranial 8.0 mm / 10.0 mm2025-03-04
04056481145637 - Alignment Guide Tube Cranial 4.9 mm / 8.0 mm2025-03-04
04056481145903 - Alignment Bone Anchor Cranial 2.1 mm / 4.9 mm2025-03-04

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