FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 08809447652177
·
Model: Operator's Goggle
·
Lutronic Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- N/A
- Primary DI
- 08809447652177
- Version / Model
- Operator's Goggle
- Company Name
- Lutronic Corporation
- Labeler DUNS
- 688282516
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-06
- Public Version
- 1
- Public Version Date
- 2018-09-06
- Public Version Status
- New
- Public Device Record Key
- b3185de2-5091-4657-a6d9-36e647962ba3
Device Description
Operator's Goggle for DENTA II
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| ONG | Powered Laser Surgical Instrument With Microbeam\Fractional Output | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47878 | Dental carbon dioxide laser system | A mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input energy is used to excite carbon dioxide (active medium) to emit a beam of intense, coherent, monochromatic electromagnetic (EM) radiation for application in dental procedures, mainly to excise or vaporize tissue in the oral cavity. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch. It typically emits energy at a wavelength of 10,600 nm (far infrared) to tissues through a handpiece; it may be operated in continuous-wave or pulsed modes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809447652177 | GS1 |
Customer Contacts
- Phone
- 215-205-2219
- [email protected]