Safety Needle Cartridge 6-MNP 1.5 Exceed US

Basic Information

• Brand Name: Safety Needle Cartridge 6-MNP 1.5 Exceed US
• Primary DI: EMTDEMNPAED06USMP0
• Version / Model: EMNPAED06USMP
• Catalog Number: EMNPAED06USMP
• Company Name: MT.DERM GmbH
• Labeler DUNS: 329216357
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-23
• Public Version: 7
• Public Version Date: 2024-01-11
• Public Version Status: Update
• Public Device Record Key: ef2ff88f-fdf2-4f75-af63-1a064c691101
• Distribution End Date: 2022-01-01

Device Description

The Safety Needle Cartridge is an accessory of Exceed AD61USMP.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QAI	Powered Microneedle Device	General, Plastic Surgery	878.4430	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EMTDEMNPAED06USMP0	HIBCC
Package	EMTDEMNPAED06USMP1	HIBCC	Box	8	Not in Commercial Distribution	2022-01-01

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 59 – 77 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 30 – 65 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 30 – 65 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 59 – 77 Degrees Fahrenheit