FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Cellfina System Disposable Tray
DI: 00840763100414
·
Model: CK1 Rev J
·
ULTHERA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cellfina System Disposable Tray
- Primary DI
- 00840763100414
- Version / Model
- CK1 Rev J
- Company Name
- ULTHERA, INC.
- Labeler DUNS
- 010981554
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-18
- Public Version
- 1
- Public Version Date
- 2019-07-26
- Public Version Status
- New
- Public Device Record Key
- c46b0bd1-7d19-40e0-80f1-844b1fb58b76
- Distribution End Date
- 2019-07-18
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 |
|---|---|---|---|---|
| OUP | Powered Surgical Instrument For Improvement In The Appearance Of Cellulite | General, Plastic Surgery | 878.4790 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62248 | Mechanical skin contouring system injection/transection set | A collection of sterile components of a mechanical skin contouring system intended to temporarily minimize the manifestation of cellulite by transection of the cellulite-tethering fibrous tissue by motorized mechanical means. It consists of template plates, needle and microblade assemblies to guide instruments, and a vacuum-assisted capture unit to control the tissue being treated. The device is placed on the skin, an area of skin/subcutaneous tissue is drawn by suction into a dome, and local anaesthesia is infiltrated prior to subcutaneous transection by a motorized cutting tool. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840763100414 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161885 | 000 |