FDA.report

Geniant Cranial

Primary DI
08800050902505
Brand
Geniant Cranial
Company
KOH YOUNG TECHNOLOGY INC.
Model
M_MN30-CSDB000
Device description
Sterile Robot Drape(25ea)
Published
2025-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions

SubmissionSupplement
K241333000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800050902505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800050902505088000509025058800050902505

GMDN Terms

TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
695406977
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08800050904769Geniant CranialKY-PPR-0030-A2026-03-09
08800050904776Geniant CranialM_MN30-QC000002026-03-09
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
08800050901454Geniant CranialM_MN30-CMQ00002025-02-20

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