FDA.reportPublic FDA data

Geniant Cranial

Primary DI
08800050904776
Brand
Geniant Cranial
Company
KOH YOUNG TECHNOLOGY INC.
Model
M_MN30-QC00000
Device description
Patient Positioning Module-R Case
Published
2026-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08800050904776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800050904776088000509047768800050904776

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
695406977
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800050904769Geniant CranialKY-PPR-0030-A2026-03-09
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
08800050901447Geniant CranialM_MN30-CMAN0002025-02-20

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