FDA UDI
In Commercial Distribution
🇺🇸 United States
Aveli
DI: 00850036790006
·
Model: AVE001
·
Revelle Aesthetics, Inc.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Aveli
- Primary DI
- 00850036790006
- Version / Model
- AVE001
- Company Name
- Revelle Aesthetics, Inc.
- Labeler DUNS
- 117419977
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-02-14
- Public Version
- 5
- Public Version Date
- 2024-02-23
- Public Version Status
- Update
- Public Device Record Key
- 3306d449-0d8d-448b-9f6d-ba171dd8c666
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| GDI | Dissector, Surgical, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
| FTD | Lamp, Surgical | General, Plastic Surgery | 878.4580 | 2 |
| OUP | Powered Surgical Instrument For Improvement In The Appearance Of Cellulite | General, Plastic Surgery | 878.4790 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65870 | Cellulite fibrous tether manual cutter | A hand-held manual surgical instrument intended to be used for the subdermal localization and mechanical transection of cellulite-tethering septal fibrous tissue, as a skin-contouring treatment to minimize the manifestation of cellulite. It consists of a handle with mechanical controls and a distal blade/hook designed to be inserted through a puncture in the skin surface, whereby it is manoeuvred to subcutaneously engage and cut (release) the septal fibrous tissue. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850036790006 | GS1 |
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity