Frameless SRS MASK SET EXTENDED 49660

GUDID 04056481142704

Brainlab AG

Head/neck procedure positioner
Primary Device ID04056481142704
NIH Device Record Key1fa3890f-7b2e-4ce0-bd6b-8668410b319f
Commercial Distribution StatusIn Commercial Distribution
Brand NameFrameless SRS MASK SET EXTENDED
Version Model Number49660
Catalog Number49660
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481142704 [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 Date2022-12-29

Devices Manufactured by Brainlab AG

04056481140809 - Curve 1.2 Dual Navigation Station2025-03-26
04056481141677 - Cirq Robotic Disposable Kinematic Unit2025-03-26
04056481125967 - Patient Mask Set 2025-03-18
04056481142698 - Frameless SRS MASK SET CRANIAL2025-03-18
04056481142704 - Frameless SRS MASK SET EXTENDED 2025-03-18
04056481142704 - Frameless SRS MASK SET EXTENDED 2025-03-18
04056481145620 - Alignment Reduction Tube Cranial 8.0 mm / 10.0 mm2025-03-04
04056481145637 - Alignment Guide Tube Cranial 4.9 mm / 8.0 mm2025-03-04
04056481145903 - Alignment Bone Anchor Cranial 2.1 mm / 4.9 mm2025-03-04

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.