FDA.reportPublic FDA data

UltraPoint

Primary DI
00849593009669
Brand
UltraPoint
Company
LifeSync Corporation
Model
NM-016383
Device description
DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 28 GA., 37 MM NEEDLE, 2 FT. (0.6 M) SINGLE ORANGE 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
00849593009676PackageGS125Not in Commercial Distribution
00849593009669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849593009676008495930096768495930096760849593009676
00849593009669008495930096698495930096690849593009669

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.

Sterilization Methods#

Method table
Method

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
00849593019576American BiosurgicalCB-AB 1000 (S)AB 1000 (S)2021-06-03
00849593025508AMCCB-93523R2023-11-01
00849593017268AMCLWM-3500024/3A2020-02-21
00849593022934AMCCB-92324R-152019-07-19
00849593022965AMCCB-92330-152019-07-19
00849593023436AMCCB-925006-62019-09-18
00849593023474AMCCB-925007-42019-09-17
00849593007887AMCCBM-73331R2019-04-04
00849593008150AMCCBM-61596R2019-04-04
00849593023481AMCCB-925007-62019-04-03
00849593003032AMCCB-92386MX2019-04-02
00849593003216AMCCB-92578R2019-04-02
00849593004947AMCCB-92383R2019-04-02
00849593022927AMCCB-92324R2019-04-02
00849593023184AMCCB-92385R2019-04-02
00849593023191AMCCB-923862019-04-02
00849593023405AMCCB-925006-122019-04-02
00849593023627AMCCB-925852019-04-02
00849593000451AMCCB-86540R2019-04-01
00849593001144AMCLW-3500024/3A2018-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720791375140NeuroguardTechnomed Engineering B.V.IKT2026-06-05
08720791375164NeuroguardTechnomed Engineering B.V.IKT2026-06-05
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