Patient Mask Set 41130

GUDID 04056481125967

Brainlab AG

Head/neck procedure positioner
Primary Device ID04056481125967
NIH Device Record Key785b9d49-020d-4306-997b-261112727454
Commercial Distribution StatusIn Commercial Distribution
Brand NamePatient Mask Set
Version Model Number41130
Catalog Number41130
Company DUNS314482980
Company NameBrainlab AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com
Phone+49899915680
Emailcontact@brainlab.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481125967 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2025-03-18
Device Publish Date2022-12-28

Devices Manufactured by Brainlab AG

04056481146108 - Hex Screwdriver 4 mm2025-08-22
04056481146528 - Hex Screwdriver 2.5 mm2025-08-22
04056481146672 - Mixed Reality Spine Navigation2025-08-08
04056481145941 - Disposable Loop-X Source Drape (1 Pc)2025-08-04 The source drape is intended to sterile cover the source (cone beam) of the Loop-X.
04056481145934 - Disposable Loop-X Detector Drape (1 Pc)2025-08-01 Is intended to sterile cover the detector of the Loop-X.
04056481145330 - CRANIAL 4PI HEADREST PLATFORM2025-07-04
04056481145347 - CRANIAL 4PI HEAD SUPPORT STANDARD2025-07-04
04056481145354 - CRANIAL 4PI STEREOTACTIC MASK 3.2MM (5 PCS.)2025-07-04

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