Scanner Reference Adapter Bodytom 19134-10

GUDID 04056481004668

Brainlab AG

Robotic surgical navigation system
Primary Device ID04056481004668
NIH Device Record Keyeb9760b9-b33b-43a7-8a2d-2458e0de5f7a
Commercial Distribution Discontinuation2019-12-12
Commercial Distribution StatusNot in Commercial Distribution
Brand NameScanner Reference Adapter Bodytom
Version Model Number19134-10
Catalog Number19134-10
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
GS104056481004668 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

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

Devices Manufactured by Brainlab AG

04056481145439 - PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE S2025-06-25
04056481145446 - PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE L2025-06-25
04056481146320 - Alignment Software Spine2025-06-24 The Alignment Software Spine is intended to support the surgeon in reaching a predefined position through semi-automated alignme
04056481145521 - ULTRASOUND NAVIGATION ADAPTER (ALOKA C42K)2025-06-23
04056481145538 - ULTRASOUND NAVIGATION ADAPTER (ALOKA S31KP) 2025-06-23
04056481145828 - Microscope Navigation 2025-06-19
04056481143985 - Mixed Reality Spine Navigation2025-06-09
04056481140809 - Curve 1.2 Dual Navigation Station2025-03-26

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