FDA.reportPublic FDA data

Chalgren

Primary DI
00816020020665
Brand
Chalgren
Company
CHALGREN ENTERPRISES
Model
285-32-24TP
Catalog number
285-32-24TP
Device description
Reusable Ground Electrode, EMG, 32 mm Nickel Plated Disc
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953220000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K95322000032MM NICKEL PLATED DISC ELECTRODEChalgren Enterprises, Inc.1995-10-06GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816020020665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816020020665008160200206658160200206650816020020665

GMDN Terms#

Term, Definition table
TermDefinition
Analytical non-scalp cutaneous leadAn insulated metal wire(s) designed to conduct electrical signals between a skin electrode(s) or needle electrode(s) [electrode not included] and a device designed for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), bioelectrical impedance]. It is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length24Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
408-847-3994sales@jarisupply.com

Regulatory Flags#

DUNS number
085932630
Device count
1
Lot or batch
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

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Primary DI, Brand, Company table
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00382830063876NatusXLTEKGXY2026-10-15
00382830063883NatusXLTEKGXY2026-10-15
00382830063890NatusXLTEKGXY2026-10-15
00382830063906NatusXLTEKGXY2026-10-15
00382830063913NatusXLTEKGXY2026-10-15
00382830063920NatusXLTEKGXY2026-10-15
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00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.GXY2026-09-04
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08720791379179EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379209EZ1020Technomed Engineering B.V.GXY2026-08-07
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
00850080988633AUVONUAN HEALTHCARE LIMITEDGXY2026-07-17
00850080988602AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988619AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16