FDA UDI
In Commercial Distribution
🇺🇸 United States
Vividimage D HD
DI: 00724995195090
·
Model: RLM27HD3NPWR
·
BLACK DIAMOND VIDEO, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Vividimage D HD
- Primary DI
- 00724995195090
- Version / Model
- RLM27HD3NPWR
- Catalog Number
- RLM27HD3NPWR
- Company Name
- BLACK DIAMOND VIDEO, INC.
- Labeler DUNS
- 556373053
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-31
- Public Version
- 3
- Public Version Date
- 2024-05-03
- Public Version Status
- Update
- Public Device Record Key
- e4d9844e-120f-44d1-9700-602b8829406c
Device Description
The Vividimage D 27-inch HD Surgical Display, without power, is designed for the most demanding surgical environments through its delivery of realistic color accuracy, improved visualization of fine structure details, and enhanced depth perception.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| KQM | CAMERA, SURGICAL AND ACCESSORIES | General, Plastic Surgery | 878.4160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36612 | Image display unit, colour | An electrically-powered visual display unit (VDU), commonly known as a screen or a monitor [e.g., cathode-ray tube (CRT) or liquid crystal display (LCD)], designed for displaying graphical information (e.g., values or images measured/acquired by other devices) in colour. The device(s) that generates the visual data is not included with the display unit. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00724995195090 | GS1 |
Customer Contacts
- Phone
- +1(800)548-4873
- [email protected]