AccessGUDID - DEVICE: HIDREX USA (04250571300610)

GUDID

Device Identifier (DI) Information

Brand Name: HIDREX USA
Version or Model: DVP1000 Package HF AL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ION17110US
Company Name: HIDREX GmbH

Primary DI Number: 04250571300610
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 326742426 *Terms of Use

Device Description: HIDREX USA DVP1000 Iontophoresis Device Package Hand/Foot (Aluminum Electrode Plates, US Type A Plug)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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.	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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6affcc39-5416-47de-b144-d743bf9faedd
Public Version Date: November 09, 2022
Public Version Number: 3
DI Record Publish Date: February 08, 2017