FDA UDI
In Commercial Distribution
🇺🇸 United States
SPECTRA
DI: 08809447650272
·
Model: SPECTRA SL body U120V
·
Lutronic Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- SPECTRA
- Primary DI
- 08809447650272
- Version / Model
- SPECTRA SL body U120V
- Company Name
- Lutronic Corporation
- Labeler DUNS
- 688282516
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-27
- Public Version
- 4
- Public Version Date
- 2021-07-26
- Public Version Status
- Update
- Public Device Record Key
- 8d22f1f4-ddc3-4ea3-b10c-e8e814074b08
Device Description
SPECTRA SL body U120V (SPECTRA laser system)
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
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36150 | General/multiple surgical frequency-doubled solid-state laser system | A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam, in which the frequency is doubled, intended to precisely cut, excise/vaporize, and coagulate tissues for general surgery, and/or multiple specialized surgical applications (non-dedicated). It includes a light source, delivery/positioning device(s), and controls/foot-switch and 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 |
|---|---|---|---|---|---|---|
| Package | 8809447650432 | GS1 | Wooden box | 1 | In Commercial Distribution | |
| Primary | 08809447650272 | GS1 |
Customer Contacts
- Phone
- 215-205-2219
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 70 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 20 – 30 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 70 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius