FDA.reportPublic FDA data

NuFACE

Primary DI
00858398007008
Brand
NuFACE
Company
Nuface
Model
30440
Device description
Leave-On Gel Primer 10oz
Published
2018-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GYBMedia, Electroconductive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GYBMedia, ElectroconductiveNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161654000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161654000NuFACE Gel PrimerCarol Cole Company2016-12-30GYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858398007008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858398007008008583980070088583980070080858398007008

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023980008
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810075943276NuFACE421942026-01-27
00810075944570NuFACE422512026-01-27
00810075944952NuFACE422602025-08-28
00810075941418NuFACE421162023-06-08
00810075941449NuFACE420192023-06-08
00850019720228NuFACE420002023-06-08
00850019720235NuFACE420012023-06-08
00850019720280NuFACE420062023-06-08
00850019720303NuFACE420082023-06-08
00850019720556NuFACE420102023-06-08
00850019720563NuFACE420112023-06-08
00850019720655NuFACE420162023-06-08
00850019720662NuFACE420152023-06-08
00850019720679NuFACE420202023-06-08
00810075940121NuFACE420712021-03-19
00810075940145NuFACE420732021-03-19
00810075940176NuFACE420742021-03-19
00810075940183NuFACE420772021-03-19
00810075940206NuFACE420792021-03-19
00810075940213NuFACE420822021-03-19

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Primary DI, Brand, Company table
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00197998355363Solventum™Solventum US LLCGYB2026-02-15
00197998355400Solventum™Solventum US LLCGYB2026-02-15
00197998355370Solventum™Solventum US LLCGYB2026-02-15
00197998355417Solventum™Solventum US LLCGYB2026-02-15
06973602730795FyneLookTOP-RANK HEALTH CARE CO., LTD.GYB2025-10-23
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06973602730627MedvatTOP-RANK HEALTH CARE CO., LTD.GYB2025-04-23
06973602730610MedvatTOP-RANK HEALTH CARE CO., LTD.GYB2025-03-18
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