FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Braun Silk.expert Pro 5
DI: 00069055886366
·
Model: PL5014
·
PROCTER & GAMBLE MANUFACTURING COMPANY, THE
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Braun Silk.expert Pro 5
- Primary DI
- 00069055886366
- Version / Model
- PL5014
- Company Name
- PROCTER & GAMBLE MANUFACTURING COMPANY, THE
- Labeler DUNS
- 004238200
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-08
- Public Version
- 3
- Public Version Date
- 2024-09-25
- Public Version Status
- Update
- Public Device Record Key
- 4c00c71b-a3e0-486b-8504-d2946496668e
- Distribution End Date
- 2023-09-08
Device Description
Light Based Over-The-Counter Hair Removal
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
| OHT | Light based over-the-counter hair removal | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65776 | Home-use intense pulsed light hair removal unit | A hand-held, electrically-powered device designed to be used in the home to produce strong, controlled flashes of filtered light in the wavelength range of 400 - 1200nm [intense pulsed light (IPL)] for self-removal of unwanted hair. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10069055886363 | GS1 | Box | 2 | Not in Commercial Distribution | 2023-09-08 |
| Primary | 00069055886366 | GS1 |
Customer Contacts
- Phone
- +1(800)272-8611
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius