FDA UDI
In Commercial Distribution
🇺🇸 United States
CEFLA
DI: 08033837933038
·
Model: VENUS PLUS
·
CEFLA SOCIETA' COOPERATIVA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CEFLA
- Primary DI
- 08033837933038
- Version / Model
- VENUS PLUS
- Catalog Number
- 96601080
- Company Name
- CEFLA SOCIETA' COOPERATIVA
- Labeler DUNS
- 429341410
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-23
- Public Version
- 1
- Public Version Date
- 2022-12-01
- Public Version Status
- New
- Public Device Record Key
- 142b200e-a559-489d-aae8-fd1145b5fd4b
Device Description
The device is a dental operating light intended to illuminate oral structures and operating areas during dental treatment.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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 |
|---|---|---|---|---|
| EAZ | Light, Operating, Dental | Dental | 872.4630 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12351 | Reflective dental room light | A mains electricity (AC-powered) device designed for use in dentistry to project an intense and focused beam of light typically into or around the oral cavity of a patient to illuminate the site of a dental examination or procedure. It is constructed as a curved reflector with a dedicated central light bulb that produces and focuses the light, an outer housing with handles for dental staff to hold when manoeuvring the light head, and a jointed support arm. This device may be incorporated into a dental delivery system or be fixed separately to the ceiling or other support. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033837933038 | GS1 |
Customer Contacts
- Phone
- +1 (704)598-0020
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 25 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal