Joimax® Intracs® EM K-Wire Drill Guide W 18 mm x D 28 mm x H 60 mm

Primary DI
04250337118008
Brand
Joimax® Intracs® EM K-Wire Drill Guide W 18 mm x D 28 mm x H 60 mm
Company
Joimax GmbH
Model
JINTDG182860
Published
2021-11-12
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
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192663000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192663000Joimax Intracs SystemJoimax GmbH2020-07-30OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250337118008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250337118008042503371180084250337118008

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic surgical navigation/tracking systemAn assembly of devices intended for tracking spatial markers attached to a surgical instrument(s) and/or the patient, based on movement through a variable electromagnetic (EM) field. It is designed to generate visual diagrams of the relative position/orientation of the instrument/marker during surgery and may additionally allow surgical navigation through overlay of radiological images [e.g., ultrasound (US)]. It consists of a console with display and an EM field generator/receiver; spatial markers, instruments, a foot switch, or trolley may in addition be packaged with the system. It is intended for use during multiple types of surgical procedure (e.g., breast, gastrointestinal, lung).

Regulatory Flags#

DUNS number
344267187
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250337121015Combo Optic AdapterADAPTC12026-10-19
04250337106531Percusys® PlusJMPP0535PSJMPP0535PS2020-01-03
04250337118022Intracs®JINTST15JINTST152022-12-30
04250337118039Intracs®JINTST18JINTST182022-12-30
04250337118046Intracs®JINTST23JINTST232022-12-30
04250337116530Joimax® Intracs® EM System Integrated Navigation Tracking & Control SystemJINT01S2021-11-12
04250337116547Joimax® Intracs® EM Panel PCJINTPC11052021-11-12
04250337116554Joimax® Intracs® EM Control UnitJINTCU11152021-11-12
04250337116561Joimax® Intracs® EM Field GeneratorJINTFG11252021-11-12
04250337116585Joimax® Intracs® EM Patient TrackerJINTPT22352021-11-12
04250337116592Joimax® Intracs® EM Sensor ClipJINTSC22052021-11-12
04250337116608Joimax® Intracs® EM Sensor Wire 150JINTSW22152021-11-12
04250337116615Joimax® Intracs® EM Sensor Wire 180JINTSW22182021-11-12
04250337116622Joimax® Intracs® EM Sensor Wire 230JINTSW22232021-11-12
04250337116646Joimax® Intracs® EM Mounting Arm f field Generator mounting arm + rail clampJINTMA11352021-11-12
04250337117667Joimax® Intracs® EM Mounting Arm f. Patient Mapper mounting arm + rail clampJINTMAP11362021-11-12
04250337117988Wire cutterJINTWC2021-11-12
04250337117995Joimax® Intracs® EM Y-AdapterJINTYA352021-11-12
04250337118015K-Wire w/ thread, Trocar w. 15 mm thread, round 1.5 mm x 150 mmJKW15152021-11-12
04250337118213Joimax® Intracs® EM Patient Mapper - APJINTPM2245-AP2021-11-12

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10705034648200VELYSMedos International SàrlOLO2026-10-09
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00889024673403NavitrackER®Orthosoft IncOLO2026-06-26
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07613252196259FLUOROMAPStryker Leibinger GmbH & Co. KGOLO2025-01-28
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