FDA.reportPublic FDA data

Columbia Scientific

Primary DI
00850243006167
Brand
Columbia Scientific
Company
COLUMBIA SCIENTIFIC LLC
Model
Columbia 06
Catalog number
Columbia 06
Device description
Columbia 06 set of lead wires with clips to be used with Columbia 600 electrodes
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00850243006167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850243006167008502430061678502430061670850243006167

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation leadA non-sterile, insulated, electrical conducting wire intended to be used to connect a transcutaneous electrical stimulation electrode to an electrical stimulus generator (e.g., TENS system generator), or a wire having a distal end that splits and terminates as electrodes which are placed on the patient for the transmission of electrical stimulation. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
130667863
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850243006006Columbia Scientific600600-102016-09-23
00850243006013Columbia Scientific600B600B-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

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