FDA.reportPublic FDA data

SafePrep

Primary DI
18054655031840
Brand
SafePrep
Company
SPES MEDICA SPA
Model
NPREP010E-1
Published
2021-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KOYDegreaser, Skin, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOYDegreaser, Skin, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18054655031840PrimaryGS10
08054655031843Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805465503184018054655031840
08054655031843080546550318438054655031843

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.

Regulatory Flags#

DUNS number
514029771
Device count
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18054655007630Disposable Adhesive Surface ElectrodesDENIS020252025-11-21
18054655007623Disposable Adhesive Surface ElectrodesDENIS020252016-06-17
18054655008415Disposable EMG needle electrodesDSFN3804537072025-03-03
18054655023357Disposable EMG needle electrodesDSFN3804525062025-03-03
08054655008418Disposable EMG needle electrodesDSFN3804537072025-03-03
08054655023350Disposable EMG needle electrodesDSFN3804525062025-03-03
08054655036657MR Conditional Disposable EEG Cup ElectrodeDCPEX-29B2025-02-24
18054655025986Urethral Catheter ElectrodeUE0032025-02-24
18054655026006Urethral Catheter ElectrodeUE0052025-02-24
18054655030386Urethral Catheter ElectrodeUE0172025-02-24
18054655028062Tech Tape - Adhesive TapeTAPE024-252019-10-17
18054655025627Tech Dots - Adhesive and Conductive GelDOT024-252019-09-16
18054655010876Spes Medica Subdermal Needle ElectrodesMN2013D10S2020-08-11
18054655012894Spes Medica Pudendal ElectrodePUD00012020-03-11
18054655020790Connection cableSBM1AE0012024-05-13
18054655021704Connection cableSBM1AE0022024-05-13
18054655021711Connection cableSBM1AE0032024-05-13
18054655023661AC Cream - Conductive PasteACCREAM250V-32021-12-22
18054655030034Connection cableSBM1AE0042024-05-13
18054655030720IOM Stimulator ProbesSI1B0185S2526D2021-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00616784150529Adhesive Tape Remover Pads, For Professional and Hospital Use Dynarex CorporationKOY2025-09-26
17290101427817Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDKOY2023-09-19
37290101427811Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDKOY2023-09-19
00616784150826Electrode Skin Prep PadsDynarex CorporationKOY2022-05-10
00810180842716Electrode Skin Prep PadsDynarex CorporationKOY2022-05-10
00616784150819Electrode Skin Prep PadsDYNAREX CORPORATIONKOY2022-05-10
00714196390004Adhesive Tape Remover PadsSion Brands LLCKOY2021-09-09
08054655031843SafePrepSPES MEDICA SRLKOY2021-08-05
10714196821000Adhesive Tape Remover PadsSion Brands LLCKOY2020-09-01
00310819000475PDI® Electrode Prep PadPROFESSIONAL DISPOSABLES INTERNATIONAL, INC.KOY2020-08-03
10310819000472PDI® Electrode Prep PadPROFESSIONAL DISPOSABLES INTERNATIONAL, INC.KOY2020-08-03
18054655026020Tech StickSPES MEDICA SPAKOY2019-10-23