AccessGUDID - DEVICE: Exceed (EMTDAD61USMP0)

GUDID

Device Identifier (DI) Information

Brand Name: Exceed
Version or Model: AD61USMP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AD61USMP
Company Name: MT.DERM GmbH

Primary DI Number: EMTDAD61USMP0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 329216357 *Terms of Use

Device Description: The Exceed microneedling device is intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainless steel needles. Exceed consists of - Control Unit - Handpiece with handpiece cable - Handpiece Holder - Power Supply - Instructions for Use

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
Storage Environment Temperature: between 14 and 104 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 54 and 107 KiloPascal
Handling Environment Temperature: between 59 and 77 Degrees Fahrenheit
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 107 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bfe8c597-d9f7-403a-aa26-d8c4f5900c65
Public Version Date: May 25, 2026
Public Version Number: 8
DI Record Publish Date: October 23, 2018