FDA.reportPublic FDA data

Skull Reference Screwdriver Handle

Primary DI
04056481144708
Brand
Skull Reference Screwdriver Handle
Company
Brainlab SE
Model
52174
Published
2023-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GXLScrewdriver, Skullplate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXLScrewdriver, SkullplateNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056481144708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056481144708040564811447084056481144708

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic/optical surgical navigation device tracking systemA mobile assembly of mains electricity (AC-powered) devices intended to provide a physician with both electromagnetic (EM) and optical tools to track manual surgical instruments and locate target anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, an EM field generator, a camera, and sensors/localizers 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].

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
314482980
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056481122751Sterilization Tray Standards Cranial Accessories523152020-10-21
04056481122867Sterilization Tray Frameless Biopsy System523042020-10-21
04056481122874Sterilization Tray Varioguide523032020-10-21
04056481095406STERILIZATION TRAY SPINE BASIC/ANT/UNIV52306A52306A2020-04-02
04056481122812STERILIZATION TRAY HIP REPLACEMENT52309523092020-04-02
04056481122904Sterilization Tray Trauma / Knee Arthroscopy523002020-01-31
04056481122805Sterilization Tray Hip Resurfacing52310523102019-09-27
04056481004835Em Sterilization Tray Basic Instruments18099-08A18099-08A2016-09-15
04056481002718Headband Reference Star - Connector41877-1041877-102016-09-15
04056481003715Mscope Adapter Hs/Moeller Hi-R 700/100041767-8541767-852016-09-15
04056481141363CRANIAL 4PI CT TABLE OVERLAY434302022-05-31
04056481006884ELEMENTS LEAD LOCALIZATION1.026338-022016-11-18
04056481131920Registr. Matrix Imri Ge Headholder19202C19202C2016-09-17
04056481143985Mixed Reality Spine Navigation1.02025-05-31
04056481144609ExacTrac Dynamic 2.02025-02-19
04056481144654Viewer 5.45.42024-11-05
04056481004101Target Positioner Leksell40700-20A40700-20A2016-09-15
04056481006525Em Disposable Stylet18097180972018-02-08
04056481138769Elements Trajectory Planning2.026250-02C2017-06-14
04056481141981HIP77.02020-06-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07610733850600OPERACEPB SWISS TOOLS AGGXL2024-09-24
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07610733850624OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850655OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850693OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850709OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733850716OPERACEPB SWISS TOOLS AGGXL2024-09-24
07610733851966OPERACEPB SWISS TOOLS AGGXL2024-09-24
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04056481145606HEX SCREWDRIVER T-HANDLE (2.5 MM)Brainlab SEGXL2023-10-19
00888233048361SEEG LONG BOLT DRIVERBIOMET MICROFIXATION, INCGXL2023-06-07
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04056481144715Skull Reference Screwdriver BladeBrainlab SEGXL2023-05-05
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00856482008122BATTERY PACK, KLS-SD-2000, SINGLEPRO-DEX, INC.GXL2022-03-29
00862377000140BATTERY PACK, KLS-SD-1000, SINGLEPRO-DEX, INC.GXL2022-03-29
00856482008016KLS E-Coupling AdapterPRO-DEX, INC.GXL2022-03-29
00856482008115KLS MaxDriver 2 PRO-DEX, INC.GXL2022-03-29
00856482008207Pro-Dex Surgical DriverPRO-DEX, INC.GXL2022-03-29