FDA.reportPublic FDA data

Resident Expert Software Module

Primary DI
00873263008089
Brand
Resident Expert Software Module
Company
FHC, INC.
Model
C0258-00808
Catalog number
C0258
Device description
Guideline 4000™ Resident Expert Software Module, 1x
Published
2020-03-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

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
K092192000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092192000WAYPOINT STEREOTACTIC SYSTEMFHC, Inc.2010-02-12HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00873263008089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00873263008089008732630080898732630080890873263008089

GMDN Terms#

Term, Definition table
TermDefinition
Neurological stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)326-2905fhcinc@fh-co.com

Regulatory Flags#

DUNS number
108179458
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

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10873263009618microTargeting™ ElectrodeMTDWLP(BP)(BP11)-00961MTDWLP(BP)(BP11)2026-03-12
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00873263002254STar™ Drive XL Frame Adapter70-FA-RD-XL-0022570-FA-RD-XL2016-09-17
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00873263002322STar™ Drive Frame Adapter70-FA-LX-0023270-FA-LX2016-09-17
00873263002360microTargeting™ STar™ Array Insertion Tube Extractor70-CN-ET-0023670-CN-ET2016-09-17
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00873263006184STar™ Drive Frame Adapter70-FA-GP-0061870-FA-GP2017-08-29
00873263008546STar™ Drive Frame Adapter70-FA-LX-NN-0085470-FA-LX-NN2022-09-26

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