AccessGUDID - DEVICE: SkinPen Precision Microneedling System (00863221000330)

GUDID

Device Identifier (DI) Information

Brand Name: SkinPen Precision Microneedling System
Version or Model: REF100/REF101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: F5SP004
Company Name: Bellus Medical, LLC

Primary DI Number: 00863221000330
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005677967 *Terms of Use

Device Description: SkinPen Assembly (includes SkinPen Precision hand-piece, charging base, and AC Adapter).

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 [?]
DEN160029	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a4db67d6-6200-44fb-a616-123178eff4ef
Public Version Date: December 03, 2024
Public Version Number: 8
DI Record Publish Date: April 09, 2018