FDA UDI
In Commercial Distribution
🇺🇸 United States
MSDS DCD Option Kit GMPP
DI: 00817495024011
·
Model: FIN103337
·
Candela Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MSDS DCD Option Kit GMPP
- Primary DI
- 00817495024011
- Version / Model
- FIN103337
- Catalog Number
- FIN103337
- Company Name
- Candela Corporation
- Labeler DUNS
- 053468385
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-26
- Public Version
- 1
- Public Version Date
- 2024-07-04
- Public Version Status
- New
- Public Device Record Key
- 1cc752e8-6984-4338-baa5-f44b3cac3678
Device Description
MSDS DCD Option Kit GMPP
Device Characteristics
- Single Use
- No
- 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
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65509 | Dermatological laser beam producing handpiece | A hand-held component of a professional, high-powered, dermatological laser system designed to both generate and direct a therapeutic laser (diode laser) for dermatological applications (e.g., hair removal, treatment of dermal lesions). This device is connected to a control unit which supplies power to the handpiece and allows control of the treatment. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817495024011 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201111 | 000 |