FDA UDI
In Commercial Distribution
🇺🇸 United States
Centauri 2
DI: 00860013851552
·
Model: QED-9500
·
QED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Centauri 2
- Primary DI
- 00860013851552
- Version / Model
- QED-9500
- Company Name
- QED, INC.
- Labeler DUNS
- 877534289
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-21
- Public Version
- 1
- Public Version Date
- 2025-05-29
- Public Version Status
- New
- Public Device Record Key
- 029cf7b8-4d82-47d7-918c-6b855222e31d
Device Description
Portable Halogen Headlight
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 |
|---|---|---|---|---|
| HPP | Headlamp, Operating, Battery-Operated | Ophthalmic | 886.4335 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46807 | Head-worn lamp | An electrically-powered lamp mounted on a headband, helmet frame, or spectacles and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack; it is not a fibreoptic light. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860013851552 | GS1 |
Customer Contacts
- Phone
- 859-231-0338
- [email protected]