FDA.reportPublic FDA data

ADVANCE

Primary DI
10851221006114
Brand
ADVANCE
Company
NEUROMETRIX, INC.
Model
NC-S33
Device description
Superficial Peroneal Biosensor (Right) Individual
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JXEDevice, Nerve Conduction Velocity Measurement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXEDevice, Nerve Conduction Velocity MeasurementNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041320000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041320000MODIFICATION TO NC-STATNeurometrix, Inc.2004-08-12JXE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851221006114PackageGS16In Commercial Distribution
00851221006117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085122100611410851221006114
00851221006117008512210061178512210061170851221006117

GMDN Terms#

Term, Definition table
TermDefinition
Electrode conductive mediumA non-sterile substance intended to be used as a medium for the efficient transmission of electrical signals between an electrode and the body, and for the reduction of the isolation properties of the skin. It is typically in the form of a gel, paste, spray or cream and is usually used in electrocardiography, defibrillation and diathermy. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
781-314-2781rainer_maas@neurometrix.com

Regulatory Flags#

DUNS number
957536014
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851221006087NC-stat DPNCheckNC-DP2DB-025, DB-0502016-12-01
00851221006100ADVANCENC-S322016-09-07
00851221006117ADVANCENC-S332016-09-07
00851221006124ADVANCENC-S342016-09-07
00851221006131ADVANCENC-S412016-09-07
00851221006148ADVANCENC-S422016-09-07
00851221006162ADVANCENC-S722016-09-07
00851221006193ADVANCENC-S812016-09-08
00851221006209ADVANCENC-S822016-09-08
00851221006216ADVANCENC-S912016-09-08
00851221006223ADVANCENC-S922016-09-08
00851221006230ADVANCENC-S932016-09-08
00851221006247ADVANCENC-S942016-09-08
00851221006056DPNCheck 2.0NC-0402022-12-20
00851221006575DPNCheck, ChinaNC-030-C2022-12-20
00851221006582DPNCheck, JapanNC-030-JFD2022-12-20
00851221006094ADVANCENC-S312016-09-07
00851221006155ADVANCENC-S712016-09-07
00851221006179ADVANCENC-S732016-09-07
00851221006186ADVANCENC-S742016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816022023657DPNCheck IMPULSE MEDICAL TECHNOLOGIES, INC.JXE2026-01-09
00816022023664DPNCheckIMPULSE MEDICAL TECHNOLOGIES, INC.JXE2026-01-09
00816022023671DPNCheckIMPULSE MEDICAL TECHNOLOGIES, INC.JXE2026-01-09
00816022023688DPNCheckIMPULSE MEDICAL TECHNOLOGIES, INC.JXE2026-01-09
00816022023695DPNCheckIMPULSE MEDICAL TECHNOLOGIES, INC.JXE2026-01-09
00816022023701DPNCheckIMPULSE MEDICAL TECHNOLOGIES, INC.JXE2026-01-09
00816022023718DPNCheckIMPULSE MEDICAL TECHNOLOGIES, INC.JXE2026-01-09
00840067103555Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-11-15
00840067103562Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-11-15
00840067103623Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-11-15
00840067103630Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-11-15
00840067103982Sierra SummitCADWELL INDUSTRIES, INC.JXE2024-11-15
00840067103999CadwellCADWELL INDUSTRIES, INC.JXE2024-08-23
00840067102992Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-08-23
00840067103517Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-06-21
00840067103524Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-06-21
00840067102879Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-03-04
00840067102886Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-03-04
00840067102893Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-03-04
00840067102909Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-03-04
00840067102916Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-03-04
00840067103609Cadwell GuardianCADWELL INDUSTRIES, INC.JXE2024-03-04
00887868560880Ultra-Drive® ToolBiomet Orthopedics, LLCJXE2023-09-07
00887868560897Ultra-Drive® ToolBiomet Orthopedics, LLCJXE2023-09-07
00887868560903Ultra-Drive® ToolBiomet Orthopedics, LLCJXE2023-09-07
00887868560910Ultra-Drive® ToolBiomet Orthopedics, LLCJXE2023-09-07
00887868560927Ultra-Drive® ToolBiomet Orthopedics, LLCJXE2023-09-07
00887868560941Ultra-Drive® ToolBiomet Orthopedics, LLCJXE2023-09-07
00887868560958Ultra-Drive® ToolBiomet Orthopedics, LLCJXE2023-09-07
00851221006056DPNCheck 2.0NeuroMetrix, Inc.JXE2022-12-20