FDA.reportPublic FDA data

Geniant Cranial

Primary DI
08800050902413
Brand
Geniant Cranial
Company
KOH YOUNG TECHNOLOGY INC.
Model
M_MN30-CNPT000
Device description
Navigation Probe Tip Tray
Published
2025-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241333000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241333000Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.2025-01-17HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800050902413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800050902413088000509024138800050902413

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
695406977
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
08800050904769Geniant CranialKY-PPR-0030-A2026-03-09
08800050904776Geniant CranialM_MN30-QC000002026-03-09
08800050901621Geniant CranialMN30-CRSC0022025-02-20
08800050901638Geniant CranialMN30-CRSC0032025-02-20
08800050901287Geniant CranialM_MN30-CMF00002025-02-20
08800050901294Geniant CranialM_MN30-CMM00002025-02-20
08800050901300Geniant CranialM_MN30-CMR00002025-02-20
08800050901317Geniant CranialM_MN30-CMRN0002025-02-20
08800050901324Geniant CranialM_MN30-CMP00002025-02-20
08800050901331Geniant CranialM_MN30-CMS00002025-02-20
08800050901348Geniant CranialM_MN30-CML00002025-02-20
08800050901355Geniant CranialM_MN30-CMU00002025-02-20
08800050901362Geniant CranialM_MN30-CME00002025-02-20
08800050901379Geniant CranialM_MN30-CMG00002025-02-20
08800050901386Geniant CranialM_MN30-CMH00002025-02-20
08800050901393Geniant CranialM_MN30-CLL00002025-02-20
08800050901409Geniant CranialM_MN30-CMB00002025-02-20
08800050901416Geniant CranialM_MN30-CMC00002025-02-20
08800050901423Geniant CranialM_MN30-CMD00002025-02-20
08800050901430Geniant CranialM_MN30-CMA00002025-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719878691024Nao Trac SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691208Foot ControllerBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691246Display ScreenBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691307USB MouseBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691420Power Supply CordBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878691468Power Supply Cord (US) 5mBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878692021Surgical Equipment Drape PacksBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693004Reference StylusBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693042Tag SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878693127Tag Support ArmBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878694001Instrument Registration Platform CoverBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695022Instrument Holder SBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695046Instrument Adaptor (3 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695060Instrument Adaptor (4 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695084Instrument Adaptor (5 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695107Instrument Adaptor (8 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695121SEEG AdaptorBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695145Catheter AdaptorBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695169Thumb Screw of Instrument HolderBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695183Set Screw of Instrument HolderBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695206Pin Screw of Instrument AdaptorBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695220Catheter Adaptor_3.5mmBRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695244Instrument Adaptor (1.8 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695268Instrument Adaptor (2 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695282Instrument Adaptor (2.2 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695305Instrument Adaptor (2.5 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695329Instrument Adaptor (2.8 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695343Instrument Adator (3.2 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695367Instrument Adaptor (3.5 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25
04719878695381Instrument Adaptor (4.6 mm)BRAIN NAVI BIOTECHNOLOGY CO., LTD.HAW2026-07-25