FDA.reportPublic FDA data

Sterile LeadConfirm

Primary DI
17290114064009
Brand
Sterile LeadConfirm
Company
ALPHA OMEGA ENGINEERING CO. LTD.
Model
Sterile LeadConfirm
Catalog number
STR-000083-00
Published
2023-05-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
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
K191739000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191739000Sterile LeadConfirmAlpha Omega Engineering , Ltd.2020-01-02GZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290114064009PackageGS110In Commercial Distribution
07290114064002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729011406400917290114064009
07290114064002072901140640027290114064002

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, single-useA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
531856466
Device count
1
DM exempt
false
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
false

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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Primary DI, Brand, Company table
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00650551005919DEPTHALON®PMT CORPORATIONGZL2026-05-15
00650551005926DEPTHALON®PMT CORPORATIONGZL2026-05-15
00841823108814Anchor Bolt Kit, LSB StyleAd-Tech Medical Instrument CorporationGZL2026-04-08
10873263009625microTargeting™ ElectrodeFHC, INC.GZL2026-03-12
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10873263009410microTargeting™ ElectrodeFHC, INC.GZL2025-05-21
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00856895008658OneRF Ablation SystemNEUROONE MEDICAL TECHNOLOGIES CORPORATIONGZL2024-12-02
10873263009250microTargeting™ ElectrodeFHC, INC.GZL2024-09-02
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03664539003900NADIXI MEDICALGZL2024-04-03
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