SkinPen

GUDID 00863221000316

BELLUS MEDICAL, LLC

Electronic cosmetic micro-needling handpiece

• Primary Device ID: 00863221000316
• NIH Device Record Key: 4ae8898f-881e-4843-9214-71747564c66b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SkinPen
• Version Model Number: 100
• Company DUNS: 005677967
• Company Name: BELLUS MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850035498354 [Package]; Package: [1 Units]; In Commercial Distribution
GS1	00863221000316 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN160029

FDA Product Code

• QAI: Powered Microneedle Device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-09

On-Brand Devices [SkinPen]

• 00863221000361: 1
• 00863221000354: 24 count of Treatment Kit singles
• 00863221000347: 101
• 00863221000330: SkinPen Box (includes SkinPen Precision hand-piece, charging base, and AC Adapter).
• 00863221000323: Treatment kit which includes a sterile, disposable cartridge tip, a hydrogel 510k exempt medical
• 00863221000316: 100
• 00863221000309: 014
• 20863221000327: Case of 18 single treatment kits.
• 10863221000320: Case of 12 SkinPen Precision Treatment Kits