SafePrep

Primary DI
08054655031843
Brand
SafePrep
Company
SPES MEDICA SRL
Model
NPREP010E-1
Published
2021-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
514029771
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
08054655020793Connection cableSBM1AE0012024-05-13
08054655021707Connection cableSBM1AE0022024-05-13
08054655021714Connection cableSBM1AE0032024-05-13
08054655030037Connection cableSBM1AE0042024-05-13
08054655023664AC Cream - Conductive PasteACCREAM250V-32021-12-22
08054655031034Disposable Adhesive Surface ElectrodesTEON2F50902021-03-23
08054655031041Disposable Adhesive Surface ElectrodesTEON2F100150F2021-03-23
08054655030723IOM Stimulator ProbesSI1B0185S2526D2021-02-04
08054655010879Spes Medica Subdermal Needle ElectrodesMN2013D10S2020-08-11
08054655012897Spes Medica Pudendal ElectrodePUD00012020-03-11

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
18054655031840SafePrepSPES MEDICA SPAKOY2021-08-05
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