FDA.reportPublic FDA data

Instrument Adaptor (5.2 mm)

Primary DI
04719878695404
Brand
Instrument Adaptor (5.2 mm)
Company
BRAIN NAVI BIOTECHNOLOGY CO., LTD.
Model
COIH030C
Device description
Instrument Adaptor has one pin screw for equipping with a Standard Neurosurgical Instrument directly. Instrument Adaptors have holes with different diameters. This model of Adaptor has an internal diameter of 5.2 mm. 3 pcs are supplied with the main device (optional).
Published
2026-07-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K242575000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242575000Stereotaxic Guiding Surgical Devices, NaoTrac SBrain Navi Biotechnology Co., Ltd.2025-05-23HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719878695404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719878695404047198786954044719878695404

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic neuronavigation/planning systemA mobile assembly of mains electricity (AC-powered) electronic and optical devices designed to receive and analyse patient magnetic resonance imaging (MRI) images and position landmarks manually or automatically on these images, then register the images by the mean of a three-dimensional (3-D) optical positioning system (frameless stereotactic neuronavigation) to provide real-time relative positioning for the treatment probes and instruments. It is typically used by healthcare providers in psychiatry, neuropsychiatry, and neurology for preoperative planning, in particular for consecutive image-guided transcranial magnetic stimulation (TMS) treatment sessions.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
656312401
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719878691024Nao Trac SFPNT02012026-07-25
04719878691208Foot ControllerCOFP10002026-07-25
04719878691246Display ScreenCODS00012026-07-25
04719878691307USB MouseCOCO10032026-07-25
04719878691420Power Supply CordCOWI02052026-07-25
04719878691468Power Supply Cord (US) 5mCOWI02062026-07-25
04719878692021Surgical Equipment Drape PacksFPSD71012026-07-25
04719878693004Reference StylusFPRS01012026-07-25
04719878693042Tag SFPTA10002026-07-25
04719878693127Tag Support ArmCOTA04822026-07-25
04719878694001Instrument Registration Platform CoverFPIR02112026-07-25
04719878695022Instrument Holder SFPIH00112026-07-25
04719878695046Instrument Adaptor (3 mm)COIH03012026-07-25
04719878695060Instrument Adaptor (4 mm)COIH03022026-07-25
04719878695084Instrument Adaptor (5 mm)COIH03032026-07-25
04719878695107Instrument Adaptor (8 mm)COIH03042026-07-25
04719878695121SEEG AdaptorFPIH03102026-07-25
04719878695145Catheter AdaptorFPIH04012026-07-25
04719878695169Thumb Screw of Instrument HolderCOSC60112026-07-25
04719878695183Set Screw of Instrument HolderCOSC30122026-07-25

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