Disposable Precalibrated Stylet 55793

GUDID 04056481005177

Brainlab AG

Robotic surgical navigation system
Primary Device ID04056481005177
NIH Device Record Key041b3eca-b834-4361-a371-408233ba02ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Precalibrated Stylet
Version Model Number55793
Catalog Number55793
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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
GS104056481005153 [Package]
Package: [1 Units]
In Commercial Distribution
GS104056481005160 [Package]
Package: [10 Units]
In Commercial Distribution
GS104056481005177 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.