FDA UDI
In Commercial Distribution
🇺🇸 United States
Trophy Skin
DI: 00851561006099
·
Model: Labelle
·
TROPHY SKIN, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Trophy Skin
- Primary DI
- 00851561006099
- Version / Model
- Labelle
- Company Name
- TROPHY SKIN, INC
- Labeler DUNS
- 014294023
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-06
- Public Version
- 3
- Public Version Date
- 2020-01-28
- Public Version Status
- Update
- Public Device Record Key
- aaebd0ca-0cba-487c-91ae-2ac709da3b6f
Device Description
Labelle Ultrasonic Skin Spatula
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GFE | Brush, Dermabrasion, Powered | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32388 | Dermabrasion brush, rotary | A device with wire bristles that is rotated in a power-driven tool to plane the skin (surgical removal of the epidermis and as much of the dermis as necessary) to remove scars, tattoos, pigmented nevi, fine wrinkles, or other irregularities. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851561006099 | GS1 |
Customer Contacts
- Phone
- 866-546-4664
- [email protected]