AccessGUDID - DEVICE: VIVACE ULTRA (G055ABMVIVM121)

GUDID

Device Identifier (DI) Information

Brand Name: VIVACE ULTRA
Version or Model: VERSION 1.0
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ABMVIVM12
Company Name: Aesthetics Biomedical, Inc.

Primary DI Number: G055ABMVIVM121
Issuing Agency: HIBCC
Commercial Distribution End Date: May 06, 2025
Device Count: 10
Labeler D-U-N-S® Number*: 033599752 *Terms of Use

Device Description: 10 CARTRIDGES CONTAINING 60 NON-INSULATED MICRONEEDLES IN A SQUARE PATTERN

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:	Yes
Prescription Use (Rx):	No
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?
66286	Intradermal radio-frequency ablation system needle electrode	An electrical conductor intended to be introduced into the dermal layer of the skin (intradermal) to deliver radio-frequency (RF) current in a monopolar configuration for coagulation/ablation, to treat skin conditions [typically superficial skin lesions (e.g., telangiectasia, cherry angioma, venous lake, skin tags) and/or acne]. It is intended to be used in conjunction with an appropriate RF generator and attached to a probe handle (not included). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories
OUH	Skin Resurfacing Rf Applicator
IYO	System, Imaging, Pulsed Echo, Ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221574	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: c538f5e0-b54c-4f57-838b-e71f16e84eda
Public Version Date: May 09, 2025
Public Version Number: 3
DI Record Publish Date: December 30, 2022