Reference Array Spine Clamps (4 Spheres) 55759

GUDID 04056481005207

Brainlab AG

Robotic surgical navigation system
Primary Device ID04056481005207
NIH Device Record Keyd8bf4870-7691-425b-83d3-99d93c1c6f5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameReference Array Spine Clamps (4 Spheres)
Version Model Number55759
Catalog Number55759
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49899915680
Emailcontact@brainlab.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481005207 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04056481005207]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2016-09-15

Devices Manufactured by Brainlab AG

04056481145514 - Z-touch Laser Registration Pointer2025-02-21 The Z-touch Laser Registration Pointer is a battery powered wireless laser pointer for quick and accurate patient registration w
04056481144906 - Spine &Trauma Navigation2024-11-22
04056481146238 - PATIENT REFERENCE ARRAY SPINE & TRAUMA2024-11-22
04056481146603 - ADAPTER SHORT FOR PATIENT REFERENCE CLAMP2024-11-22
04056481146610 - ADAPTER X-PRESS FOR PATIENT REFERENCE ARRAY2024-11-22
04056481143916 - Spine Planning2024-11-13
04056481144654 - Viewer 5.42024-11-13
04056481143527 - DICOM Proxy2024-11-01

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