AccessGUDID - DEVICE: Safety Needle Cartridge 6-MNP 1.5 Exceed US (EMTDEMNPAED06USMP0)

GUDID

Device Identifier (DI) Information

Brand Name: Safety Needle Cartridge 6-MNP 1.5 Exceed US
Version or Model: EMNPAED06USMP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EMNPAED06USMP
Company Name: MT.DERM GmbH

Primary DI Number: EMTDEMNPAED06USMP0
Issuing Agency: HIBCC
Commercial Distribution End Date: January 01, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 329216357 *Terms of Use

Device Description: The Safety Needle Cartridge 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:	Yes
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?
61222	Cosmetic micro-needling electronic handpiece cartridge, professional	A device intended to be fitted to an electronic cosmetic micro-needling handpiece for the creation of high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin as part of collagen induction therapy (CIT). It is a small, sealed cartridge containing micro-needles intended to be fitted to the distal tip of the handpiece; it does not include any injectable materials. It is intended to be used by a healthcare provider in a clinical setting. It is not intended to be used for energy-based skin treatment. This is a single-use 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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 59 and 77 Degrees Fahrenheit
Storage Environment Humidity: between 30 and 65 Percent (%) Relative Humidity
Handling Environment Humidity: between 30 and 65 Percent (%) Relative Humidity
Storage Environment Temperature: between 59 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ef2ff88f-fdf2-4f75-af63-1a064c691101
Public Version Date: January 11, 2024
Public Version Number: 7
DI Record Publish Date: October 23, 2018