Sterilization Tray Robotic Spinal Drilling for Cirq

GUDID 04056481141226

Brainlab AG

Sterilization/disinfection container
Primary Device ID04056481141226
NIH Device Record Key5b34d15c-fe8e-4cc0-8a46-03de3227c08d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSterilization Tray Robotic Spinal Drilling for Cirq
Version Model Number52332
Company DUNS314482980
Company NameBrainlab AG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104056481141226 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FSMTray, Surgical, Instrument
OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-29
Device Publish Date2020-10-21

Devices Manufactured by Brainlab AG

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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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