Multiple-Tip-Pointer Shaft Starlink 55791A

GUDID 04056481001315

Brainlab AG

Robotic surgical navigation system
Primary Device ID04056481001315
NIH Device Record Key69ac86e7-7609-4e4f-800b-732cdcdce6ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameMultiple-Tip-Pointer Shaft Starlink
Version Model Number55791A
Catalog Number55791A
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
GS104056481001315 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04056481001315]

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

04056481144753 - Drill Guide Array2024-06-12
04056481144760 - Drill Guide Depth Control (60 - 100 mm)2024-06-12
04056481144777 - Drill Guide Depth Control (0 - 60 mm)2024-06-12
04056481144784 - Drill Guide Tube (4.5 mm)2024-06-12
04056481144791 - Drill Guide Tube (3.2 mm)2024-06-12
04056481144807 - Drill Guide Tube (2.6 mm)2024-06-12
04056481144814 - Drill Guide Tube (2.4 mm)2024-06-12
04056481144821 - Drill Guide Tube (2.0 mm)2024-06-12

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