FDA.reportPublic FDA data

N/A

Primary DI
04250307605651
Brand
N/A
Company
inomed Medizintechnik GmbH
Model
801007
Device description
RM Vertical Arc 85°
Published
2022-09-27
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
04250307605651PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250307605651042503076056514250307605651

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
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250307604388N/A5346442026-10-01
04250307604425N/A5346722026-10-01
04250307604449N/A5346742026-10-01
04250307613526N/A5346472026-10-01
04250307613533N/A5346482026-10-01
04250307613540N/A5346762026-10-01
04250307601424ISIS5040062022-09-16
04250307607280ISIS5040042022-09-16
04250307607297ISIS5040052022-09-16
04250307607440ISIS5041802022-09-05
04250307607563ISIS5042852022-09-05
04250307608997ISIS5042612022-09-05
04250307609000ISIS5042712022-09-05
04250307609017ISIS5042812022-09-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06974813832728NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
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06974813832759NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
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06974813832827NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
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