FDA.reportPublic FDA data

N/A

Primary DI
04250307605606
Brand
N/A
Company
inomed Medizintechnik GmbH
Model
801000
Device description
RM Stereotaxy unit
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
04250307605606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250307605606042503076056064250307605606

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
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
04250307606245N/A8034012023-02-03
04250307606269N/A8034052023-02-03
04250307606740N/A8990402023-02-03
04250307605613N/A8010032022-09-27
04250307605620N/A8010042022-09-27
04250307605637N/A8010052022-09-27

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00850088866001CBYONMED-SURGICAL SERVICES, INC.HAW2026-09-25
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00199150054442ZEISS PENTERO 800SMEDTRONIC NAVIGATION, INC.HAW2026-09-21
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