FDA.reportPublic FDA data

J-Needle Navi WL 120, trocar, 11 G

Primary DI
04250337118985
Brand
J-Needle Navi WL 120, trocar, 11 G
Company
Joimax GmbH
Model
JINTJT123010
Published
2026-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
04250337118985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250337118985042503371189854250337118985

GMDN Terms#

Term, Definition table
TermDefinition
Spinal needle, single-useA sharp bevel-edged, hollow tubular instrument designed for short-term use to withdraw a sample of cerebrospinal fluid (CSF), assist introduction of a spinal guidewire or catheter (e.g., lumboperitoneal shunt, intrathecal catheter), and/or deliver contrast media and/or anaesthetic or analgesic agents intrathecally (subarachnoid) or into a vertebral disc, either directly or using the needle-through-needle technique. It is typically fenestrated, spring-tipped, and made of metal and/or plastic materials; some types may be semi-rigid and include a stylet for support during handling. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49721255140info@joimax.com

Regulatory Flags#

DUNS number
344267187
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250337119661Endo-Kerrison ShaftEKS245555402026-10-28
04250337120674Inner Drill Reamer 4.0 mm, cannulatedDRC2440242026-10-28
04250337120681Outer Drill, bluntDRC227341B2026-10-28
04250337120698Outer Drill, crownDRC227341C2026-10-28
04250337120810Inner Drill Reamer 4,0 mm, kanülliert, reusableDRC244024R2026-10-28
04250337120872Camera Head Ocular for Camsource® DuoCSD4K01CO2026-10-28
04250337120988Optic CouplerCSD4K01COV2026-10-28
04250337120995Fibre optic cableCSLC02502026-10-28
04250337121008Fiber Optic Cable Adapter joimax/WolfCSLC0250.L12026-10-28
04250337121817Endo-Kerrison ShaftEKS246550402026-10-28
04250337121879CuretteDEC2645122026-10-28
04250337121992DissectorJDA264519C2026-10-28
04250337122104iLESSYS® Delta Access TrayTDT502550DL-12026-10-28
04250337122111iLESSYS® Delta Resection TrayTDT502550DL-22026-10-28
04250337106784Percusys® PlusJMPP0535MSJMPP0535MS2020-01-03
04250337106791Percusys® PlusJMPP0540MSJMPP0540MS2020-01-03
04250337106807Percusys® PlusJMPP0545MSJMPP0545MS2020-01-03
04250337106814Percusys® PlusJMPP0550MSJMPP0550MS2020-01-03
04250337106821Percusys® PlusJMPP0635MSJMPP0635MS2020-01-03
04250337106838Percusys® PlusJMPP0640MSJMPP0640MS2020-01-03

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04056481148201Sterilization Tray Accessories SpineBrainlab SEOLO2026-10-27
04056481148218Sterilization Tray Accessories Spine & TraumaBrainlab SEOLO2026-10-27
04056481148225Sterilization Tray Accessories Spine MISBrainlab SEOLO2026-10-27
00852776006713CORUS Navigation Access System-G2LXProvidence Medical Technology, Inc.OLO2026-10-26
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00887868579608ROSA® RoboticsOrthosoft IncOLO2026-10-26
00887868579615ROSA® RoboticsOrthosoft IncOLO2026-10-26
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00887868579639ROSA® RoboticsOrthosoft IncOLO2026-10-26
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00889024705999NavitrackerOrthosoft IncOLO2026-10-26
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00763000786434MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-25
00763000777616CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-23
04056481146207Spine PlanningBrainlab SEOLO2026-10-23
00840466901011PrimusSPINAL ELEMENTS, INC.OLO2026-10-22
00840606184656OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187503OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
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