FDA.reportPublic FDA data

Alignment Software Cranial with LITT

Primary DI
04056481146337
Brand
Alignment Software Cranial with LITT
Company
Brainlab SE
Model
2.1
Published
2025-02-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243698000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243698000Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITTBrainlab AG2025-01-28HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481146337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481146337040564811463374056481146337

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic/optical surgical navigation/tracking systemA mobile assembly of electrically-powered devices intended to provide a physician with both electromagnetic (EM) and optical tools to track manual surgical instruments and locate target anatomical structures, commonly with respect to pre-acquired images and/or real-time data [e.g., computed tomography (CT), ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, an EM field generator, a camera, and sensors/spatial markers for attachment to the patient and instruments for position/movement tracking. It is used for multiple procedures (e.g., craniotomy) in various fields [e.g., ear/nose/throat (ENT), craniomaxillofacial (CMF) surgery].

Regulatory Flags#

DUNS number
314482980
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056481147648Quip Link Instrument Tracking Array For 3 Marker Spheres M581932026-10-29
04056481147655Quip Link Instrument Tracking Array For 3 Marker Spheres ML581942026-10-29
04056481147662Quip Link Instrument Tracking Array For 3 Marker Spheres L581952026-10-29
04056481147679Quip Link Instrument Tracking Array For 3 Marker Spheres L1581962026-10-29
04056481147686Quip Link Instrument Tracking Array For 3 Marker Spheres L2581972026-10-29
04056481147693Quip Instrument Adapter Clamp Size S582102026-10-29
04056481147709Quip Instrument Adapter Clamp Softgrip Size M582112026-10-29
04056481147716Quip Instrument Adapter Clamp Softgrip Size L582122026-10-29
04056481147723Quip Instrument Adapter Clamp Softgrip Size XL582132026-10-29
04056481147730Quip Instrument Adapter Clamp For Rectangular Instruments582142026-10-29
04056481147747Quip Instrument Adapter Clamp For Cylindrical Instruments582152026-10-29
04056481147754Quip Instrument Adapter Extension 50 mm582162026-10-29
04056481147761Quip Instrument Adapter 45° Angled582172026-10-29
04056481145323Patient Reference Carbon-Clamp Spine & Trauma558232026-10-27
04056481148201Sterilization Tray Accessories Spine52306C2026-10-27
04056481148218Sterilization Tray Accessories Spine & Trauma52326A2026-10-27
04056481148225Sterilization Tray Accessories Spine MIS52313B2026-10-27
04056481148232Sterilization Tray Accessories ENT/CMF52311A2026-10-27
04056481148249Sterilization Tray Accessories Cranial (2 of 2)52305A2026-10-27
04056481146207Spine Planning3.02026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850088866018CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866025CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866032CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866049CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866056CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866063CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866070CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866087CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866094CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866100CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866117CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866124CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866131CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866148CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866155CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866162CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866179CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866186CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866193CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866209CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866216CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866223CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866230CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866247CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866254CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866261CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866278CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866285CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866292CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29
00850088866308CBYONMED-SURGICAL SERVICES, INC.HAW2026-10-29