FDA UDI
In Commercial Distribution
🇺🇸 United States
Glace
DI: 00817495025339
·
Model: FIN102955
·
Candela Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Glace
- Primary DI
- 00817495025339
- Version / Model
- FIN102955
- Company Name
- Candela Corporation
- Labeler DUNS
- 053468385
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-07
- Public Version
- 1
- Public Version Date
- 2025-10-15
- Public Version Status
- New
- Public Device Record Key
- 9b68f9b5-da74-4132-b1fa-41115167e496
Device Description
Glace Hydro dermabrasion HP BOX 20 UNITS ABRASIVE DIAMOND TIP MEDIUM GRIT
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 65745 | Dermabrasion bur | A rotary abrasive endpiece intended to be fitted to a powered motorized handpiece (not included) operated by a healthcare professional to plane the skin (surgical removal of the epidermis and as much of the dermis as necessary) for the removal of scars, tattoos, pigmented nevi, fine wrinkles, and/or other irregularities. It consists of a rough head of various shapes made of hard materials (e.g., diamond, metal carbide); it does not include bristles (i.e., not a brush). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817495025339 | GS1 |