FDA.reportPublic FDA data

UltraPoint

Primary DI
00849593009720
Brand
UltraPoint
Company
LifeSync Corporation
Model
NM-016388
Device description
DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 27 GA., 37 MM NEEDLE, 2 FT. (0.6 M) SINGLE BLUE LEADWIRE
Published
2018-11-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKTElectrode, Needle, Diagnostic Electromyograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKTElectrode, Needle, Diagnostic ElectromyographPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849593009737PackageGS125In Commercial Distribution
00849593009720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849593009737008495930097378495930097370849593009737
00849593009720008495930097208495930097200849593009720

GMDN Terms#

Term, Definition table
TermDefinition
Electromyographic needle electrode, single-useA sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
954-345-9800info@advantagemed.com

Regulatory Flags#

DUNS number
360791383
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849593000000AMCAC-6X924/CCL 2019-07-29
00849593005340LifeSyncLS-238B2022-11-21
00849593005760LifeSyncLS-2292022-11-20
00849593005807LifeSyncLS-229D2022-11-20
00849593008358AMCRPO-LW-329DS50/5A2026-02-16
00849593008365AMCRPO-LW-329DS120/5A2026-02-16
00849593009966RochesterNS-S86015-T1-10SC2018-11-20
00849593015547RochesterSE-222466-502018-11-20
00849593017312AMCLW-329DS30/5A2020-06-10
00849593017350AMCLW-329DS120/5A2020-06-24
00849593017374AMCLWM-329DS120/5A2020-06-10
00849593017398AMCLW-329DS120/5AT2020-06-10
00849593017411AMCLWM-329DS120/5AT2020-06-10
00849593017435AMCLWM-318DS50/5DR2020-06-23
00849593017619AMCLWM-229DS50/3A2020-07-09
00849593017633AMCLWM-229DS50/5A2020-07-09
00849593017657AMCLWM-229DS50/6A2020-07-09
00849593017671AMCLWM-329DS50/6A2020-07-09
00849593017695AMCLWM-229DS50/5AT2020-07-09
00849593017718AMCLWM-229DS50/5V2020-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720791370206NeuroguardTechnomed Engineering B.V.IKT2023-01-02
08720791370220NeuroguardTechnomed Engineering B.V.IKT2023-01-02
08718375869062AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869093AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869123AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869154AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869185AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869215AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869246AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869277AmbuTechnomed Engineering B.V.IKT2022-07-04
08718375869604Neurosign V4Technomed Engineering B.V.IKT2022-07-04
08718375869628Neurosign V4Technomed Engineering B.V.IKT2022-07-04
08718375869871Neurosign V4Technomed Engineering B.V.IKT2022-04-14
08718375868102Consolidated Neuro SupplyTechnomed Engineering B.V.IKT2021-06-02
08718375867129NatusTechnomed Engineering B.V.IKT2021-04-01
08718375867143NatusTechnomed Engineering B.V.IKT2021-04-01
08718375867167NatusTechnomed Engineering B.V.IKT2021-04-01
08718375867181NatusTechnomed Engineering B.V.IKT2021-04-01
08718375867204NatusTechnomed Engineering B.V.IKT2021-04-01
08718375867228NatusTechnomed Engineering B.V.IKT2021-04-01
08718375867242NatusTechnomed Engineering B.V.IKT2021-04-01
08718375867266NatusTechnomed Engineering B.V.IKT2021-04-01
08718375867280NatusTechnomed Engineering B.V.IKT2021-04-01
08718375867303NatusTechnomed Engineering B.V.IKT2021-04-01
08718375867556Technomed EuropeTechnomed Engineering B.V.IKT2021-02-24
08718375867570Technomed EuropeTechnomed Engineering B.V.IKT2021-02-24
08718375867884Technomed EuropeTechnomed Engineering B.V.IKT2021-02-24
08718375867891Technomed EuropeTechnomed Engineering B.V.IKT2021-02-24
08718375867907Technomed EuropeTechnomed Engineering B.V.IKT2021-02-24
08718375867914Technomed EuropeTechnomed Engineering B.V.IKT2021-02-24