FDA.reportPublic FDA data

Columbia Scientific

Primary DI
00850243006013
Brand
Columbia Scientific
Company
COLUMBIA SCIENTIFIC LLC
Model
600B
Catalog number
600B-10
Device description
"Columbia 600B mini-snap electrodes (.86"" diameter) with butterfly patch - 10 sets per box with (1) set of SNAP06 Lead Wires"
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K080386000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080386000COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIREColumbia Scientific Development, LLC2008-05-30GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850243006013PrimaryGS10
10850243006010Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850243006013008502430060138502430060130850243006013
1085024300601010850243006010

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation, cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-544-1560information@columbiasci.com

Regulatory Flags#

DUNS number
130667863
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850243006006Columbia Scientific600600-102016-09-23
00850243006020Columbia Scientific600600-302016-09-23
00850243006037Columbia Scientific600600-502016-09-23
00850243006044Columbia Scientific600600-1002016-09-23
00850243006051Columbia Scientific600B600B-302016-09-23
00850243006068Columbia Scientific600B600B-502016-09-23
00850243006075Columbia Scientific600B600B-1002016-09-23
00850243006082Columbia Scientific600M600M-102016-09-23
00850243006099Columbia Scientific600M600M-302016-09-23
00850243006105Columbia Scientific600M600M-502016-09-23
00850243006112Columbia Scientific600M600M-1002016-09-23
00850243006129Columbia ScientificSNAP600SNAP600-102016-09-23
00850243006136Columbia ScientificSNAP600SNAP600-302016-09-23
00850243006143Columbia ScientificSNAP600SNAP600-502016-09-23
00850243006150Columbia ScientificSNAP600SNAP600-1002016-09-23
00850243006235Columbia Scientific700700-152016-09-23
00850243006242Columbia Scientific700700-302016-09-23
00850243006259Columbia Scientific700700-502016-09-23
00850243006266Columbia Scientific700700-1002016-09-23
00850243006273Columbia Scientific700P700P-1002016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
08720791377564NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791377595NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791375591CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375614CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375638CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375652CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375676CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791374426NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374440NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374457NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374471NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374495NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374518NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374532NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374556NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374693MagstimTechnomed Engineering B.V.GXY2024-05-22
08720791372125CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372149CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372163CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372187CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372200CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372224CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372248CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372262CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372286CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372309CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372323CadwellTechnomed Engineering B.V.GXY2024-05-02