FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Nova 3
DI: 00860013851576
·
Model: QED-2050
·
QED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Nova 3
- Primary DI
- 00860013851576
- Version / Model
- QED-2050
- Company Name
- QED, INC.
- Labeler DUNS
- 877534289
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-22
- Public Version
- 1
- Public Version Date
- 2025-05-30
- Public Version Status
- New
- Public Device Record Key
- c435f5a2-40c2-43e2-9dc7-c5f1cb077652
- Distribution End Date
- 2025-05-22
Device Description
200-watt Halogen Light Source
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
- No
- 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 |
|---|---|---|---|---|
| FTD | Lamp, Surgical | General, Plastic Surgery | 878.4580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32037 | General-purpose light source | A mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860013851576 | GS1 |
Customer Contacts
- Phone
- 850-231-0338
- [email protected]