FDA.reportPublic FDA data

microTargeting™ Insertion Tube Set

Primary DI
00873263008935
Brand
microTargeting™ Insertion Tube Set
Company
FHC, INC.
Model
FC1012-00893
Catalog number
FC1012
Device description
microTargeting Array Electrode Insertion Tube Set, nonsterile, for use with mT Drive. Contains 6 of IT(AR1), 6 of IT(AR2), and 1 of IT(AR3). Individual Specifications: IT(AR1): Electrode Insertion Tube - 239.9mm, OD=0.88mm, ID=0.58mm. IT(AR2): Lower Guide Spacer - OD=1.83mm, ID=0.97mm (does not enter brain). IT(AR3): Lead Insertion Tube - 239.9mm, OD=1.83mm, ID=1.60mm. Also contains one 66-AC-AR Array Electrode Carrier and one 66-CN-ET Electrode Extraction Tool.
Published
2025-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
K011775000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011775000MICRO TARGETING DRIVE SYSTEMFHC, Inc.2001-08-30HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00873263008935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00873263008935008732630089358732630089350873263008935

GMDN Terms#

Term, Definition table
TermDefinition
Intracerebral cannula, nonimplantable, single-useA sterile, nonimplantable, rigid tube intended to be surgically inserted through the skull to access the brain (e.g., cerebral ventricles) for cerebrospinal fluid (CSF) drainage, infusion of materials, and/or for use as a port through which instruments, leads and/or probes can be passed to perform a variety of diagnostic, treatment, or surgical procedures. It is usually made of metal (e.g., stainless steel) and may include a stylet/trocar blade. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Degrees Celsius95 Degrees Celsius
Storage Environment Humidity0 Degrees Celsius95 Degrees Celsius
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
108179458
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00873263008522microTargeting™ PlatformMP-KIT-A-ST-00852MP-KIT-A-ST2023-07-26
00873263007693microTargeting™ Insertion Tube66-IT-IT2P-0076966-IT-IT2P2026-05-08
00873263007785microTargeting™ Insertion Tube66-IT(IT2)-0077866-IT(IT2)2026-05-08
00873263007792microTargeting™ Insertion Tube66-PT(IT2)-0077966-PT(IT2)2026-05-08
00873263003046WayPoint™ Surgical Kit66-WP-SKS-0030466-WP-SKS2016-09-17
00873263003190WayPoint™ Implant Kit66-WP-IKS-0031966-WP-IKS2016-09-17
00873263009604microTargeting™ Measurement Probe66-MO-31-0096066-MO-312026-03-16
00873263009468microTargeting™ PlatformMP-KIT-P-VO-00946MP-KIT-P-VO2026-03-16
00873263009475microTargeting™ Measurement Probe66-MO-31-0096066-MO-312026-03-16
10873263009625microTargeting™ ElectrodeMTDWLN(BP)(BP11)-00962MTDWLN(BP)(BP11)2026-03-12
00873263009611microTargeting™ ElectrodeMTDWLP(BP)(BP11)-00961MTDWLP(BP)(BP11)2026-03-12
10873263009618microTargeting™ ElectrodeMTDWLP(BP)(BP11)-00961MTDWLP(BP)(BP11)2026-03-12
00873263009628microTargeting™ ElectrodeMTDWLN(BP)(BP11)-00962MTDWLN(BP)(BP11)2026-03-12
00873263002254STar™ Drive XL Frame Adapter70-FA-RD-XL-0022570-FA-RD-XL2016-09-17
00873263002285STar™ Drive XL Frame Adapter70-FA-LX-XL-0022870-FA-LX-XL2016-09-17
00873263002322STar™ Drive Frame Adapter70-FA-LX-0023270-FA-LX2016-09-17
00873263002360microTargeting™ STar™ Array Insertion Tube Extractor70-CN-ET-0023670-CN-ET2016-09-17
00873263006047WayPoint™ Entry Offset Mounting Hub66-MP-EH-0060466-MP-EH2018-04-01
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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