FDA UDI
In Commercial Distribution
🇺🇸 United States
FotoFinder leviacam
DI: 04260158450089
·
Model: V1
·
FotoFinder Systems GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FotoFinder leviacam
- Primary DI
- 04260158450089
- Version / Model
- V1
- Company Name
- FotoFinder Systems GmbH
- Labeler DUNS
- 342763695
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-07
- Public Version
- 1
- Public Version Date
- 2023-08-15
- Public Version Status
- New
- Public Device Record Key
- 87ab27f1-e9c9-47a7-94b7-e36b56104159
Device Description
FotoFinder leviacam is a video dermatoscope to take images of intact skin, scalp, hair and nail with high magnification and cross-polarized light. It is a non-invasive device for imaging and documentation only.
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
- 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 |
|---|---|---|---|---|
| IBJ | Light, Microscope | Pathology | 864.3600 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47160 | Dermatoscope, digital | An electrically-powered, hand-held instrument intended to be used for the microscopic examination of the external skin layers through the production of digital images (i.e. without direct optical view). The device has a built-in light source(s) and an electronic magnification system that provides the user with digital images of the structures of the epidermis and epidermal-dermal junction for visualization during dermatoscopy (also known as dermascopy). This device is commonly used for the examination of skin structures and to assess abnormal colour and pattern changes of pigmented skin lesions (e.g., spongy birth marks, malignant melanoma). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260158450089 | GS1 |