FDA.reportPublic FDA data

N/A

Primary DI
04250307606245
Brand
N/A
Company
inomed Medizintechnik GmbH
Model
803401
Device description
Target point simulator
Published
2023-02-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2
IYEAccelerator, Linear, MedicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250307606245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250307606245042503076062454250307606245

GMDN Terms#

Term, Definition table
TermDefinition
Neurological stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
340782259
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250307609949N/A5140-522-6062019-12-17
04250307610075N/A5140-532-6312019-12-17
04250307610105N/A5140-532-6382019-12-17
04250307610167N/A5140-533-6362019-12-17
04250307610181N/A5140-530-6552019-12-17
04250307610198N/A5140-530-6562019-12-17
04250307612871Adapter cable touchproof for ALM Tube5308622026-05-29
04250307612888Connection cable for ALM Tube5308642026-05-29
04250307601424ISIS5040062022-09-16
04250307612178N/A8030122024-08-15
04250307612185N/A8030132024-08-15
04250307605712N/A8010132023-02-03
04250307605729N/A8010142023-02-03
04250307606054N/A8031042023-02-03
04250307606269N/A8034052023-02-03
04250307606740N/A8990402023-02-03
04250307605606N/A8010002022-09-27
04250307605613N/A8010032022-09-27
04250307605620N/A8010042022-09-27
04250307605637N/A8010052022-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
006283415208297D Surgical FLASH EVD Procedural Kit7D Surgical ULCHAW2026-04-08
006283415208367D Surgical FLASH EVD Non-Sterile Kit7D Surgical ULCHAW2026-04-08
006283415208437D Surgical FLASH EVD Sterile Kit7D Surgical ULCHAW2026-04-08
00628341521352FLASH EVD System7D Surgical ULCHAW2026-04-08
00840277411815Gold MarkerRIVERPOINT MEDICAL, LLCIYE2026-03-11
04056481146429Automatic RegsitrationBrainlab SEHAW2026-02-20
04056481146702Curve NavigationBrainlab SEHAW2025-10-13
04056481145828Microscope NavigationBrainlab SEHAW2025-06-11
04056481145620Alignment Reduction Tube Cranial 8.0 mm / 10.0 mmBrainlab SEHAW2025-02-24
04056481145637Alignment Guide Tube Cranial 4.9 mm / 8.0 mmBrainlab SEHAW2025-02-24
04056481145903Alignment Bone Anchor Cranial 2.1 mm / 4.9 mmBrainlab SEHAW2025-02-24
04056481146047Cirq Robotic Tracking Array 10.0Brainlab SEHAW2025-02-24
04056481146337Alignment Software Cranial with LITTBrainlab SEHAW2025-02-24
04056481145514Z-touch Laser Registration PointerBrainlab SEHAW2025-02-13
00850002461343BiomarC®Carbon Medical Technologies, Inc.IYE2024-07-23
00850002461350Carbon Bright ®Carbon Medical Technologies, Inc.IYE2024-07-23
04056481144630Ultrasound NavigationBrainlab SEHAW2024-04-26
00850016008176VeraFormViscus Biologics LLCIYE2024-01-16
04056481144845Automatic Registration iMRIBrainlab SEHAW2023-11-20
04056481145392DRAPELINK REF ADAPTER AUTO-REG IMRIBrainlab SEHAW2023-10-16
04056481145101Automatic RegistrationBrainlab SEHAW2023-09-22
04056481143817Alignment Bone Anchor Cranial 2.1/3.8Brainlab SEHAW2023-09-18
04056481144395Alignment Guide Tube Cranial 2.5/7.5Brainlab SEHAW2023-09-18
04056481144401Alignment Guide Tube Cranial 4.0/7.5Brainlab SEHAW2023-09-18
04056481144418Alignment Guide Tube Cranial 3.8/7.5Brainlab SEHAW2023-09-18
04056481144432Alignment Reduction Tube Cranial 2.5/4.0Brainlab SEHAW2023-09-18
04056481144487Alignment Software CranialBrainlab SEHAW2023-09-18
04056481143848Cranial NavigationBrainlab SEHAW2023-08-02
04056481144500Curve Navigation 17700Brainlab SEHAW2023-05-22
04056481144685Disposable Skull Reference Bone Fixation Screw 1.5 mm x 6 mmBrainlab SEHAW2023-05-05