FDA UDI
In Commercial Distribution
🇺🇸 United States
futudent
DI: 06429810664044
·
Model: eduCam
·
Novocam Medical Innovations Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- futudent
- Primary DI
- 06429810664044
- Version / Model
- eduCam
- Catalog Number
- EDUS
- Company Name
- Novocam Medical Innovations Oy
- Labeler DUNS
- 539845795
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-04
- Public Version
- 1
- Public Version Date
- 2023-09-12
- Public Version Status
- New
- Public Device Record Key
- 9aa37789-8bad-4b74-80be-e05e051e689b
Device Description
These apparatuses are intended by the manufacturer to be used by qualified healthcare professionals to capture videos and pictures during dental and medical treatments for the purpose of documentation, providing additional information for diagnosis, following and evaluating changes of medical conditions and for educational purposes in dental and medical field.
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| KQM | Camera, Surgical And Accessories | General, Plastic Surgery | 878.4160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32265 | Surgical video camera | An electro-optical device (e.g., a CCD) designed to obtain moving-picture documentation of an open surgical procedure. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06429810664044 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 23 | Gram |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 50 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- – 80 Percent (%) Relative Humidity