FDA.report

STar™ Drive Insertion Tube Set

Primary DI
00873263002186
Brand
STar™ Drive Insertion Tube Set
Company
FHC, INC.
Model
70-IT-04-00218
Catalog number
70-IT-04
Device description
STar(TM) Drive Array Electrode Insertion Tube Set for use with microTargeting(TM) Platform, non-sterile Set Contains: 6x IT(AR18) Guide Tube, 1.83mm OD (does not enter brain) 6x IT(AR19) Insertion Tube with Stylet - 186.7mm length, 0.87mm od, 0.60mm id 1x IT(AR4) DBS Lead Insertion Tube with Stylet - 188.05mm length, 1.83mm od, 1.60mm id. 2x Insertion Tube Extractors
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HAOINSTRUMENT, SURGICAL, NON-POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00873263002186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00873263002186008732630021868732630021860873263002186

GMDN Terms

TermDefinition
Intracerebral cannula, implantableA sterile, implantable tube intended to be surgically placed in a specific area of the brain (e.g., basal ganglia) to position a deep brain electrical stimulation lead/electrode, using a stereotactic surgery system, and to function as a guide for subsequent and regular placement and/or removal of the lead/electrode. It is made of synthetic polymer materials (e.g., polyurethane) and may include a stylet/trocar blade.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity095 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)326-2905fhcinc@fh-co.com

Regulatory Flags

DUNS number
108179458
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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00873263009628microTargeting™ ElectrodeMTDWLN(BP)(BP11)-00962MTDWLN(BP)(BP11)2026-03-12
00873263009451microTargeting™ Drill Guide66-MO-30-0095966-MO-302026-02-10
00873263009574STar™ Drive Frame Adapter70-FA-LS-0095870-FA-LS2026-01-25
00873263009314Visualase Neuro Accessories9736536-0093197365362025-12-12
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00873263009338Visualase MR Stiffening Stylet9736538-0093397365382025-12-12
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00873263009352Visualase Anchor Bolt Driver Guide9736540-0093597365402025-12-12
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00873263009376Visualase Anchor Bolt Driver Guide9736542-0093797365422025-12-12
00873263009383Visualase Anchor Bolt Driver Guide9736543-0093897365432025-12-12
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00873263009499microTargeting™ Electrode35325Z-0094935325Z2025-12-02
10873263000615microTargeting™ Array Electrode Carrier and ClampFC1021-00061-FC10212018-07-16
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