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
00850080988602AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988619AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988626AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850053287411ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287428ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287442ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287459ReCureNiche Biomedical, Inc.GXY2026-07-14
00850080988589AUVONUAN HEALTHCARE LIMITEDGXY2026-07-14
06971292004318AUVONShenzhen Yuwen E-Commerce Co., Ltd.GXY2026-07-13
08682250582004Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08682250582011Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08720791378172Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378189Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378196Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378202Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378219Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378226Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378233Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378240Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378257Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378264Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378271Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378288Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378295Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378301Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378318Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378325Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378332Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378349Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378356Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08