SkinPen Precision Treatment Kit

Basic Information

• Brand Name: SkinPen Precision Treatment Kit
• Primary DI: 00863221000323
• Version / Model: F5SP013
• Catalog Number: F5SP013
• Company Name: Bellus Medical, LLC
• Labeler DUNS: 005677967
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-09
• Public Version: 11
• Public Version Date: 2023-11-03
• Public Version Status: Update
• Public Device Record Key: 6afbca98-5d85-4497-bcec-8ade7a0f83ea

Device Description

Treatment kit which includes a sterile, disposable cartridge tip, a hydrogel, and a disposable sleeve.

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: Yes
• Sterilization Methods: Ethylene Oxide

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
47764	Wound hydrogel dressing, non-antimicrobial	A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.	No	Active
12535	Medical equipment drape, single-use	A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00863221000323	GS1
Package	00850035498811	GS1	Mixed Case	24	In Commercial Distribution
Package	00850035498828	GS1	Mixed Case	24	In Commercial Distribution
Package	00850035498866	GS1	Mixed Case	12	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]