SPINE REFERENCE ARRAY (4 MARKER) 55761

GUDID 04056481139315

Brainlab AG

Robotic surgical navigation system
Primary Device ID04056481139315
NIH Device Record Keydf227023-a58b-4cc0-8ed0-8463969c23ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPINE REFERENCE ARRAY (4 MARKER)
Version Model Number55761
Catalog Number55761
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
GS104056481139315 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04056481139315]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2017-08-03

Devices Manufactured by Brainlab AG

04056481143916 - Spine Planning2024-11-13
04056481144654 - Viewer 5.42024-11-13
04056481143527 - DICOM Proxy2024-11-01
04056481144913 - CRANIAL 4PI STEREOTACTIC MASK (5 PCS.)2024-07-26
04056481144920 - CRANIAL 4PI STEREOTACTIC MASK (1 PC.)2024-07-26
04056481144937 - CRANIAL 4PI BASIC MASK (5 PCS.)2024-07-26
04056481144944 - CRANIAL 4PI BASIC MASK (1 PC.)2024-07-26
04056481144951 - CRANIAL 4PI OPEN FACE MASK (5 PCS.)2024-07-26

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