DEVICE: HIDREX USA (04250571300719)
Device Identifier (DI) Information
HIDREX USA
DP450 Package HF AL
In Commercial Distribution
ION17451US
HIDREX GmbH
DP450 Package HF AL
In Commercial Distribution
ION17451US
HIDREX GmbH
HIDREX USA DP450 Iontophoresis Device Package Hand/Foot (Aluminum Electrode Plates, US Type A Plug)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
17421 | Hyperhidrosis iontophoresis system |
An 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EGJ | Device, Iontophoresis, Other Uses |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e92ed0e4-efe4-47ea-b341-c7ac4edce062
November 09, 2022
3
February 08, 2017
November 09, 2022
3
February 08, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-844-373-9872
customer.service@hidrexusa.com 9999999999
info@hidrex.de
customer.service@hidrexusa.com 9999999999
info@hidrex.de