FDA.reportPublic FDA data

Chalgren

Primary DI
10816312025900
Brand
Chalgren
Company
CHALGREN ENTERPRISES
Model
221-222SS-535
Catalog number
221-222SS-535
Device description
Paired Fine Wire Needle Electrode, EMG, 35mm x 25g
Published
2021-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10816312025900PackageGS120In Commercial Distribution
00816312025903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081631202590010816312025900
00816312025903008163120259038163120259030816312025903

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
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
4088473994sales@jarisupply.com

Regulatory Flags#

DUNS number
085932630
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816020020450Chalgren263-9P-24BTP263-9P-24BTP2016-09-09
00816020020467Chalgren263-9P-24RTP263-9P-24RTP2016-09-09
00816020020474Chalgren264-9P-24TP264-9P-24TP2016-09-09
00816020020481Chalgren264-9P-36STP264-9P-36STP2016-09-09
00816020020498Chalgren265-9G-24BTP265-9G-24BTP2016-09-09
00816020020504Chalgren265-9G-24RTP265-9G-24RTP2016-09-09
00816020020511Chalgren265-9S-24BTP265-9S-24BTP2016-09-09
00816020020528Chalgren265-9S-24RTP265-9S-24RTP2016-09-09
00816020020535Chalgren265-9T-24BTP265-9T-24BTP2016-09-09
00816020020542Chalgren265-9T-24RTP265-9T-24RTP2016-09-09
00816020020559Chalgren266-9G-24TP266-9G-24TP2016-09-09
00816020020566Chalgren266-9S-24TP266-9S-24TP2016-09-09
00816020020573Chalgren266-9T-24TP266-9T-24TP2016-09-09
00816020020580Chalgren266-9G-36STP266-9G-36STP2016-09-09
00816020020597Chalgren266-9S-36STP266-9S-36STP2016-09-09
00816020020603Chalgren266-9T-36STP266-9T-36STP2016-09-09
00816020020610Chalgren277-930-24TP277-930-24TP2016-09-09
00816020020627Chalgren277-930-48TP277-930-48TP2016-09-09
00816020020634Chalgren277-930-36STP277-930-36STP2016-09-09
00816020020641Chalgren279-930-24TP279-930-24TP2016-09-09

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