AccessGUDID - DEVICE: MATTIOLI (08054383090006)

GUDID

Device Identifier (DI) Information

Brand Name: MATTIOLI
Version or Model: DEP SYSTEM PRO
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 33320060/B
Company Name: MATTIOLI ENGINEERING ITALIA SPA

Primary DI Number: 08054383090006
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 514081590 *Terms of Use

Device Description: Pulsed Iontophoresis Device with handpiece

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):	No
Over the Counter (OTC):	No
Kit:	No
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?
18155	Drug-delivery iontophoresis system, reusable	An assembly of portable devices that may be used as an alternative to injections to transport ionic-solution medication through the movement of ions resulting from an applied electric field, to locally administer the medication transcutaneously. It typically consists of a battery-powered current generator that supplies a constant direct current [e.g., 0.5 to 4 milliampere (mA)], a delivery electrode which typically contains a small reservoir of buffering agent and the medication (e.g., a corticosteroid or anaesthetic), a return electrode, and connecting lead wires. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EGJ	Device, Iontophoresis, Other Uses

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K042590	000

Device Exempt from Premarket Submission: No 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: 78469251-ff2d-4091-b6bc-ae219c3b22b2
Public Version Date: October 04, 2024
Public Version Number: 1
DI Record Publish Date: September 26, 2024