FDA UDI
In Commercial Distribution
🇺🇸 United States
VIVACE ULTRA
DI: G055ABMVIVM050
·
Model: VERSION 1.0
·
Aesthetics Biomedical, Inc.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VIVACE ULTRA
- Primary DI
- G055ABMVIVM050
- Version / Model
- VERSION 1.0
- Catalog Number
- ABMVIVM05
- Company Name
- Aesthetics Biomedical, Inc.
- Labeler DUNS
- 033599752
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-30
- Public Version
- 1
- Public Version Date
- 2023-01-09
- Public Version Status
- New
- Public Device Record Key
- fe6a9a90-5949-44f7-b733-fbbc3e140cd9
Device Description
INDIVIDUAL STANDARD INSULATED MICRONEEDLE CARTIDGE
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
| OUH | Skin Resurfacing Rf Applicator | General, Plastic Surgery | 878.4400 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G055ABMVIVM050 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221574 | 000 |