AccessGUDID - DEVICE: Footswitch (EMTD104802USMP0)

GUDID

Device Identifier (DI) Information

Brand Name: Footswitch
Version or Model: E104802USMP
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MT.DERM GmbH

Primary DI Number: EMTD104802USMP0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 329216357 *Terms of Use

Device Description: The Footswitch is an accessory of Exceed AD61USMP.

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:	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?
61216	Cosmetic micro-needling electronic handpiece, professional	A hand-held, electrically-powered device intended to be used in combination with a micro-needle cartridge (which contains micro-needles) to create high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin as part of collagen induction therapy (CIT). It includes controls to allow for treatment adjustments (e.g., puncture depth, frequency); a disposable micro-needle cartridge may be included. It is intended for clinical use by a healthcare provider to treat stretch marks, acne scarring, hyperpigmentation, wrinkles, and/or hair loss; it is not intended for energy-based skin treatment. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QAI	Powered Microneedle Device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Handling Environment Atmospheric Pressure: between 60 and 107 KiloPascal
Storage Environment Atmospheric Pressure: between 54 and 107 KiloPascal
Storage Environment Temperature: between 14 and 104 Degrees Fahrenheit
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 59 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 123f92b2-0c00-4342-8e6c-88009ad39571
Public Version Date: January 18, 2024
Public Version Number: 1
DI Record Publish Date: January 10, 2024

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
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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