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
OTC
false
Sterile
false
Single use
false

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/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].

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056481145804Brainlab Origin OR1.02026-08-21
04056481006525Em Disposable Stylet18097180972018-02-08
04056481141141Disposable Pre-calibrated Suction Charr. 1252185-012021-03-08
04056481145200DISPOSABLE FIXATION PIN 4.0 MM X 125 MM (10 PCS)549292023-10-17
04056481146702Curve Navigation177022025-10-13
04056481146429Automatic Regsitration2.72026-02-20
04056481146054Patient Reference Rod-Clamp Spine & Trauma558262025-09-19
04056481145613Vascular Navigation PAD2.02025-09-11
04056481146672Mixed Reality Spine Navigation1.12025-07-31
04056481145439PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE S558242025-06-17
04056481145446PATIENT REFERENCE STEEL-CLAMP SPINE & TRAUMA SIZE L558252025-06-17
04056481146320Alignment Software Spine2.12025-06-16
04056481145828Microscope Navigation1.72025-06-11
04056481143985Mixed Reality Spine Navigation1.02025-05-31
04056481145620Alignment Reduction Tube Cranial 8.0 mm / 10.0 mm564162025-02-24
04056481145637Alignment Guide Tube Cranial 4.9 mm / 8.0 mm564172025-02-24
04056481145903Alignment Bone Anchor Cranial 2.1 mm / 4.9 mm564182025-02-24
04056481146047Cirq Robotic Tracking Array 10.056302A2025-02-24
04056481146337Alignment Software Cranial with LITT2.12025-02-24
04056481145514Z-touch Laser Registration Pointer18370-10A2025-02-13

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Primary DI, Brand, Company table
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06903195298587Disposable Screwdriver BladeKontour(Xi'An) Medical Technology Co.,Ltd.GXL2024-03-22
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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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