FDA UDI
In Commercial Distribution
🇺🇸 United States
PICO LED
DI: B366LED0202
·
Model: RX1
·
Ecleris
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PICO LED
- Primary DI
- B366LED0202
- Version / Model
- RX1
- Catalog Number
- LED020/2
- Company Name
- Ecleris
- Labeler DUNS
- 043555079
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-27
- Public Version
- 1
- Public Version Date
- 2025-02-04
- Public Version Status
- New
- Public Device Record Key
- cb121724-8c83-4f61-8de9-53c7a938a319
Device Description
LED 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
- 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 |
|---|---|---|---|---|
| KYT | Light, Examination, Medical, Battery Powered | General Hospital | 880.6350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56318 | LED dental light, battery-powered | A battery-powered device designed for use in dentistry to project an intense and focused beam of light directly into or around the oral cavity of a patient via a light-emitting diode (LED), situated as the light head at the distal end of the device's light wand, to illuminate the site of a dental examination or procedure. The light head is connected to a light-intensity control unit, containing rechargeable batteries, via a flexible cable; for oral cavity illumination, the light wand may be attached to a suction cannula, a dental chair headrest, or to a retractor hooked on the patient's lower jaw. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B366LED0202 | HIBCC |
Customer Contacts
- Phone
- 786-483-7490
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 35 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal