AccessGUDID - DEVICE: Rejuvapen (00860003838112)

GUDID

Device Identifier (DI) Information

Brand Name: Rejuvapen
Version or Model: NXT Model 102
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Refine Usa, LLC

Primary DI Number: 00860003838112
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012101731 *Terms of Use

Device Description: Microneedling Skin Rejuvenation. The Rejuvapen product is used to help remove wrinkles in the face area. Microneedling skin rejuvenation or collagen induction therapy.

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?
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: 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: 02c905ab-9882-4c21-a7e3-1f6ddf0f1cd9
Public Version Date: November 03, 2023
Public Version Number: 2
DI Record Publish Date: July 20, 2023