Instr. Adp Offset-Link 45° 20Mm Starlink 55013

GUDID 04056481005375

Brainlab AG

Robotic surgical navigation system
Primary Device ID04056481005375
NIH Device Record Keyce140aca-cdbc-4722-a6be-5278792ed603
Commercial Distribution StatusIn Commercial Distribution
Brand NameInstr. Adp Offset-Link 45° 20Mm Starlink
Version Model Number55013
Catalog Number55013
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49899915680
Emailcontact@brainlab.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481005375 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04056481005375]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-03
Device Publish Date2016-09-15

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

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