Home GUDID G055ABMVIVM040 VIVACE ULTRA
Primary DI G055ABMVIVM040
Brand VIVACE ULTRA
Company Aesthetics Biomedical, Inc.
Model VERSION 1.0
Catalog number ABMVIVM04
Device description 10 CUSTOM NON-INSULATED MICRONEEDLE CARTRIDGES FOR SMALL AREAS CONCENTRATED TREATMENTS
Published 2022-12-30
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name GEI Electrosurgical, Cutting & Coagulation & Accessories
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status G055ABMVIVM041 Primary HIBCC 0 G055ABMVIVM040 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition 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.
Regulatory Flags# DUNS number 033599752 Device count 10 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00190776398484 Millennium Avalign Technologies, Inc. GEI 2026-07-16 08800020100276 INTRAcel Tip Jeisys Medical Inc. GEI 2026-07-16 08800020100283 INTRAcel Tip Jeisys Medical Inc. GEI 2026-07-16 08800020100306 INTRAcel Tip Jeisys Medical Inc. GEI 2026-07-16 08800020100313 INTRAcel Tip Jeisys Medical Inc. GEI 2026-07-16 08800020100320 INTRAcel Tip Jeisys Medical Inc. GEI 2026-07-16 08800020100337 INTRAcel Tip Jeisys Medical Inc. GEI 2026-07-16 08800020104984 DENSITY Tip Jeisys Medical Inc. GEI 2026-07-16 08800020104991 DENSITY Tip Jeisys Medical Inc. GEI 2026-07-16 08800020105004 DENSITY Tip Jeisys Medical Inc. GEI 2026-07-16 08800020105059 DENSITY Tip Jeisys Medical Inc. GEI 2026-07-16 08800020105066 DENSITY Tip Jeisys Medical Inc. GEI 2026-07-16 08800020105073 DENSITY Tip Jeisys Medical Inc. GEI 2026-07-16 08800020106827 DENSITY Tip Jeisys Medical Inc. GEI 2026-07-16 08800020107626 DENSITY Handpiece Jeisys Medical Inc. GEI 2026-07-16 08800020107633 DENSITY Handpiece Jeisys Medical Inc. GEI 2026-07-16 08800020110565 INTRAcel Handpiece Jeisys Medical Inc. GEI 2026-07-16 08800020110572 INTRAcel Handpiece Jeisys Medical Inc. GEI 2026-07-16 08800020110640 Footswitch Jeisys Medical Inc. GEI 2026-07-16 B382SD08890310101D0 Surgical Direct Surgical Direct, Inc. GEI 2026-07-14 B382SD08890320101D0 Surgical Direct Surgical Direct, Inc. GEI 2026-07-14 B382SD7720520001 Surgical Direct Surgical Direct, Inc. GEI 2026-07-14 B382SD7720585030 Surgical Direct Surgical Direct, Inc. GEI 2026-07-14 B382SD84032220032B0 Surgical Direct Surgical Direct, Inc. GEI 2026-07-14 B382SD8406210032B0 Surgical Direct Surgical Direct, Inc. GEI 2026-07-14 B382SD89029200 Surgical Direct Surgical Direct, Inc. GEI 2026-07-14 B382SD89039060 Surgical Direct Surgical Direct, Inc. GEI 2026-07-14 B382SD89139290 Surgical Direct Surgical Direct, Inc. GEI 2026-07-14 B382SD8917450 Surgical Direct Surgical Direct, Inc. GEI 2026-07-14 B382SD89179290 Surgical Direct Surgical Direct, Inc. GEI 2026-07-14