FDA.reportPublic FDA data

Disposable Applicator Cover

Primary DI
20868924000018
Brand
Disposable Applicator Cover
Company
Regenesis Biomedical, Inc.
Model
PVTC30
Device description
Disposable Applicator Covers are single-use-only and are intended to help protect the Treatment Applicator from biological contamination. The cover is non-sterile and manufactured of polyethylene terephthalate (polyester) film and contains a Radio Frequency Identification Device (RFID) tag, which guards against reuse of used Disposable Applicator Covers.
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILXDiathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILXDiathermy, Shortwave, For Use Other Than Applying Therapeutic Deep HeatPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20868924000018PrimaryGS10
00868924000014Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2086892400001820868924000018
00868924000014008689240000148689240000140868924000014

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic stimulation system application padA non-sterile pad intended to be placed on the skin of a patient, or on the parent device, to provide a contact surface for an electromagnetic stimulation applicator, and a barrier to cross-contamination between the applicator and the patient, during treatment. It is typically made of polyethylene terephthalate (polyester) film and may contain a radio-frequency identification (RFID) tag which helps prevent reuse of the pad. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
480-297-5800chavez@regenesisbio.com

Regulatory Flags#

DUNS number
018207519
Device count
30
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00868924000021Provant Infinity42102021-01-21
00868924000007Provant Therapy System42012016-09-16
00868924000038Reprieve by RegenesisA2023-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851979007282OrthoCor MedicalCaerus Corp.ILX2025-08-11
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00851979007435OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007442OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007503OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007510OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007527OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007534OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007558OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007565OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007572OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007596OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007619OrthoCor MedicalCaerus Corp.ILX2025-03-10
00851979007015OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007022OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007039OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007046OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007336OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007367OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007381OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007404OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007428OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007466OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007480OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007664OrthoCor MedicalCaerus Corp.ILX2025-03-03
00851979007671OrthoCor MedicalCaerus Corp.ILX2025-03-03
00081009308007TrueStimHi-Dow International IncorporatedILX2023-09-28
00851329005128RecoveryRxBioElectronics CorporationILX2021-03-03