FDA UDI
In Commercial Distribution
🇺🇸 United States
VITRA 2
DI: 03700542625569
·
Model: VITRA 2
·
QUANTEL MEDICAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VITRA 2
- Primary DI
- 03700542625569
- Version / Model
- VITRA 2
- Company Name
- QUANTEL MEDICAL
- Labeler DUNS
- 738574953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-12-29
- Public Version
- 1
- Public Version Date
- 2022-01-06
- Public Version Status
- New
- Public Device Record Key
- 1ba4910b-a720-42ed-bd87-6ba016552c55
Device Description
The VITRA 2 is a laser system which emits a treatment beam at 532 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye.
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
- 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 |
|---|---|---|---|---|
| 62197 | Ophthalmic solid-state laser system | An electrically-powered device assembly with a solid-state laser (exited glass/crystal rod), that might be designed to optionally utilize the diode pump laser as a direct therapeutic laser, intended for ophthalmic surgery (e.g., photocoagulation, photodisruption) and/or photostimulation of retinal pigment epithelium (RPE) cells to reverse macular degeneration. It might include a built-in slit lamp, a dosimetry sensor, and/or frequency doubling technology, however it does not include femtosecond pulsing or fundus imaging technology. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03700542625569 | GS1 |
Customer Contacts
- Phone
- +33(0)473745745
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191962 | 000 |