Suction Std (Ch 10) Starlink Frazier 55790-70

GUDID 04056481001421

Brainlab AG

Robotic surgical navigation system
Primary Device ID04056481001421
NIH Device Record Keyd479e6e5-b78c-4e17-9fd3-8a03e515f693
Commercial Distribution StatusIn Commercial Distribution
Brand NameSuction Std (Ch 10) Starlink Frazier
Version Model Number55790-70
Catalog Number55790-70
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
GS104056481001421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04056481001421]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-15

Devices Manufactured by Brainlab AG

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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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