FDA.reportPublic FDA data

PDI® Electrode Prep Pad

Primary DI
00310819000475
Brand
PDI® Electrode Prep Pad
Company
PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
Model
B59800
Catalog number
B59800
Device description
Pre-moistened pad used to remove surface skin oil and cleanse skin area in preparation for electrode placement.
Published
2020-08-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
10310819000472PackageGS1100Not in Commercial Distribution
00310819000475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1031081900047210310819000472
00310819000475003108190004753108190004750310819000475

GMDN Terms#

Term, Definition table
TermDefinition
Skin degreaserA solvent material (e.g., liquid trichloroethane or trifluoroethane) used on the skin to dissolve surface skin oil, typically in preparation for surgery. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2.6Inch
Width1.2Inch

Contacts#

Phone, Email table
PhoneEmail
800-999-6423pdicustomercare@pdihc.com

Regulatory Flags#

DUNS number
800777117
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00310819000031Prevantics® Device Large Swab C71200C712002024-02-15
00310819000482PDI® Lubricating Jelly IIT00137T001372020-10-09
00310819000499PDI® Lubricating Jelly IIT00250T002502020-10-09
00310819000307Hygea Sterile Saline WipeC22370C223702020-08-03
00310819000451PDI® Adhesive Tape Remover PadB16400B164002020-08-03
00310819001526Prevantics® Device Swab B19600B196002020-08-03
10310819000304Hygea Sterile Saline WipeC22370C223702020-08-03
10310819000458PDI® Adhesive Tape Remover PadB16400B164002020-08-03
10310819000472PDI® Electrode Prep PadB59800B598002020-08-03
10310819001523Prevantics® Device Swab B19600B196002020-08-03
00310819001779Prevantics® Device Swab StripB123STB123ST2020-08-03

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
08054655031843SafePrepSPES MEDICA SRLKOY2021-08-05
10714196821000Adhesive Tape Remover PadsSion Brands LLCKOY2020-09-01
10310819000472PDI® Electrode Prep PadPROFESSIONAL DISPOSABLES INTERNATIONAL, INC.KOY2020-08-03
18054655026020Tech StickSPES MEDICA SPAKOY2019-10-23