FDA.report

N/A

Primary DI
EINO5906009
Brand
N/A
Company
inomed Medizintechnik GmbH
Model
590600
Device description
Elekta MicroDrive, hand operated
Published
2017-07-10
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

Related Records

Product Codes

CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EINO5906009PrimaryHIBCC0

GMDN Terms

TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
340782259
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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 DIBrandModelCatalogPublished
04250307611959N/A5336502025-05-02
14250307612052N/A5309552025-05-02
14250307612069N/A5309562025-05-02
14250307612076N/A5208562025-05-02
14250307612083N/A5208552025-05-02
04250307604517ISIS5403402022-09-16
04250307612154N/A8030102024-08-15
04250307612161N/A8030112024-08-15
04250307612178N/A8030122024-08-15
04250307612185N/A8030132024-08-15
04250307610402C2 Xplore5404312024-07-26
14250307604323N/A5336662024-07-01
04250307603275N/A5306072023-10-20
04250307604074N/A5327202023-10-20
04250307604081N/A5327222023-10-20
04250307604111N/A5336222023-10-20
04250307604128N/A5336232023-10-20
04250307604135N/A5336242023-10-20
04250307604142N/A5336252023-10-20
04250307604159N/A5336262023-10-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00873263009468microTargeting™ PlatformFHC, INC.HAW2026-03-16
00873263009475microTargeting™ Measurement ProbeFHC, INC.HAW2026-03-16
08800050904769Geniant CranialKOH YOUNG TECHNOLOGY INC.HAW2026-03-09
08800050904776Geniant CranialKOH YOUNG TECHNOLOGY INC.HAW2026-03-09
00889024704213PLANNING STATION - USAMEDTECHHAW2026-02-23
00763000738334AxiEM™MEDTRONIC NAVIGATION, INC.HAW2026-02-15
00763000738341AxiEM™MEDTRONIC NAVIGATION, INC.HAW2026-02-15
00763000738402AxiEM™MEDTRONIC NAVIGATION, INC.HAW2026-02-15
00763000738433AxiEM™MEDTRONIC NAVIGATION, INC.HAW2026-02-15
04056481147808Drill Depth Stop Cranial 4.9 mmBrainlab SEHAW2026-02-11
00873263009451microTargeting™ Drill GuideFHC, INC.HAW2026-02-10
00860009258105COMPASS CYGNUS-PFS IGS SystemCompass InternationalHAW2026-01-29
00860009258112COMPASS Stereotactic SystemCompass InternationalHAW2026-01-29
07630345728975Navigation System for Knee surgeryMedacta International SAHAW2026-01-26
07630699701792Navigation System for Knee surgeryMedacta International SAHAW2026-01-26
00873263009574STar™ Drive Frame AdapterFHC, INC.HAW2026-01-25
07630030846656Navigation System for Knee surgeryMedacta International SAHAW2026-01-19
07630030846663Navigation System for Knee surgeryMedacta International SAHAW2026-01-19
00763000738488AxiEM™MEDTRONIC NAVIGATION, INC.HAW2026-01-01
00860012211906SOLOPASS 2.0 Patient Interface DeviceinTRAvent Medical Partners, L.P.HAW2025-12-11
00763000337292N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000337308N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000337315N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000337322N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000340261N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000405144N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000405151N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000927264MedtronicMEDTRONIC NAVIGATION, INC.HAW2025-09-18
00763000943219N/AMEDTRONIC NAVIGATION, INC.HAW2025-09-18
07340201502273Leksell Stereotactic SystemElekta Solutions ABHAW2025-09-17