FDA.reportPublic FDA data

Drionic TM

Primary DI
00017344000115
Brand
Drionic TM
Company
GENERAL MEDICAL COMPANY
Model
Hand/Foot Large Parts Kit
Catalog number
DHFCDCK
Device description
Drionic Hand/Foot Large Parts Kit
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EGJDevice, Iontophoresis, Other Uses

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGJDevice, Iontophoresis, Other UsesPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00017344000115PrimaryGS10
00017344000116Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00017344000115000173440001150173440001150017344000115
00017344000116000173440001160173440001160017344000116

GMDN Terms#

Term, Definition table
TermDefinition
Hyperhidrosis iontophoresis systemAn assembly of electrically-powered devices intended to be used to transport ions in tap water (water from a faucet) and/or a water solution (e.g., glycopyrrolate and aluminium chloride) to the sweat ducts of heavy sweating areas of the body (e.g., hands, underarms, or feet) in patients that suffer from excessive perspiration (hyperhidrosis) to help minimize or stop sweating. Hyperkeratotic plugs develop in the sweat ducts as a result of the currents and hyperhidrosis is controlled.

Contacts#

Phone, Email table
PhoneEmail
626 797 1051info@drionic.com

Regulatory Flags#

DUNS number
050804012
Device count
10
Premarket exempt
true
Kit
true
Combination product
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10017344000068Drionic TMPair Hand/Foot DevicesDHF22016-09-22
10017344000075Drionic TMPair Underarm DevicesDUA22016-09-22
00017344000009Drionic TMUnderarm ModulesDUAM2016-09-22
00017344000016Drionic TMHand-Foot PadsDHFPds2016-09-22
00017344000023Drionic TMUnderarm PadsDUAPds2016-09-22
00017344000030Drionic TMHand-Foot PlatesDHFPLts2016-09-22
00017344000047Drionic TMUnderarm StrapsDUAStrps2016-09-22
00017344000054Drionic TMLG Alkaline BatteryDB2016-09-22
00017344000061Drionic TMHand/Foot Sweat StopDHF2016-09-22
00017344000078Drionic TMUnderarm Sweat StopDUA2016-09-22
00017344000085Drionic TMPair LG Alkaline BatteriesDB22016-09-22
00017344000092Drionic TMUnderarm Parts KitDUADCK2016-09-22
00017344000108Drionic TMHand/Foot Parts KitDHFDCK2016-09-22
00017344000122Drionic TMUnderarm Large Parts KitDUACDCK2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10768627016497Push Patch Controlled Released 12.0NORTH COAST MEDICAL, INC.EGJ2025-12-01
00768627016995PushPatch Delicate (6)NORTH COAST MEDICAL, INC.EGJ2025-12-01
00768627016988PushPatch Delicate (6)NORTH COAST MEDICAL, INC.EGJ2025-12-01
20768627016494Push Patch Controlled Released 12.0NORTH COAST MEDICAL, INC.EGJ2025-12-01
10768627016299ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
10768627016305ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
10768627016312ActivaTek Ionto4 ButterflyNORTH COAST MEDICAL, INC.EGJ2025-04-02
10768627016282ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
20768627016296ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
20768627016302ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
20768627016319ActivaTek Ionto4 ButterflyNORTH COAST MEDICAL, INC.EGJ2025-04-02
04250571300832PhotheraHIDREX GmbHEGJ2025-01-07
08054383090006MATTIOLIMATTIOLI ENGINEERING ITALIA SPAEGJ2024-09-26
00850030915047Dupel BLUEClearlake-Tech Inc.EGJ2023-08-02
00850030915078Dupel BLUEClearlake-Tech Inc.EGJ2023-08-02
00850030915108Dupel BLUEClearlake-Tech Inc.EGJ2023-08-02
00850030915252RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915269RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915276RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915283RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915290RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915306RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915313RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915320RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915337RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915344RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915351RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915368RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915016Dupel BLUEClearlake-Tech Inc.EGJ2023-08-02
00850030915054Dupel BLUESouth Dakota Partners Inc.EGJ2023-08-02