FDA.reportPublic FDA data

Ruler and DBs holder thumb screw

Primary DI
07290114061414
Brand
Ruler and DBs holder thumb screw
Company
ALPHA OMEGA ENGINEERING CO. LTD.
Model
Ruler and DBs holder thumb screw
Catalog number
344-001110-00
Published
2024-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
GZLElectrode, Depth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZLElectrode, DepthNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051830000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051830000NEURODRIVE SYSTEMAlpha Omega , Ltd.2005-09-16GZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290114061414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290114061414072901140614147290114061414

GMDN Terms#

Term, Definition table
TermDefinition
Depth electrodeAn electrical conductor intended to be temporarily placed (< 30 days) beneath the surface of the brain to stimulate the brain or to record the brain's electrical activity (with more precise localization than a scalp electrode). It is typically a fine, flexible plastic device attached to wires that carry currents from deep and superficial brain structures. The wires are connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. The implant is particularly helpful in determining site of origin in temporal and frontal lobe epilepsy. This is a single-use device.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Regulatory Flags#

DUNS number
531856466
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290114064965HaGuide SoftwareHaGuide Software407-000024-002026-03-13
27290114060879NeuroNav with MER HeadstageNeuroNav with MER HeadstageNNW-025023-552024-01-08
27290114061364NeuroNav Pelican CaseNeuroNav Pelican Case700-000888-002024-01-08
27290114061371Universal DBS holder silicone sleeve - Pack of 5Universal DBS holder silicone sleeve - Pack of 5341-011305-05 2024-01-08
27290114061388Universal LeadConfirm cable holder silicone sleeve - Pack of 5Universal LeadConfirm cable holder silicone sleeve341-011308-05 2024-01-08
37290114061408Frame adapter thumb screw - Pack of 3Frame adapter thumb screw - Pack of 3700-001330-032024-01-08
07290014954090Sterile electrode's cable Sterile electrode's cable STR-000664-002024-01-08
07290014954816Sterile electrode's cable Sterile electrode's cable STR-000664-112024-01-08
07290014954991Neuro Omega MER HeadstageNeuro Omega MER Headstage750-000023-002024-01-08
07290016450026NeuroNav MER HeadstageMER Headstage700-005023-002024-01-08
07290114060486Power cablePlug Type B 190-000117-012024-01-08
07290114060493Power cablePlug Type G190-000117-022024-01-08
07290114060509Power cablePlug Type J190-000117-032024-01-08
07290114060516Power cablePlug Type L-4mm190-000117-042024-01-08
07290114060523Power cablePlug Type M190-000117-052024-01-08
07290114060530Power cablePlug Type I190-000117-072024-01-08
07290114060547Power cablePlug Type F190-000117-082024-01-08
07290114060554Power cablePlug Type H190-000117-092024-01-08
07290114060561Neuro Omega NeuroFortis Drive HeadstageNeuro Omega NeuroFortis Drive Headstage750-000070-002024-01-08
07290114060820Power cablePlug Type D190-000117-122024-01-08

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