FDA UDI
Not in Commercial Distribution
🇺🇸 United States
WAVENET
DI: 00380659908170
·
Model: 8065990817
·
Alcon Laboratories, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- WAVENET
- Primary DI
- 00380659908170
- Version / Model
- 8065990817
- Catalog Number
- 8065990817
- Company Name
- Alcon Laboratories, Inc.
- Labeler DUNS
- 008018525
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 4
- Public Version Date
- 2022-11-07
- Public Version Status
- Update
- Public Device Record Key
- a50088a6-e8c4-46ea-9e8d-811f5f7a552f
- Distribution End Date
- 2014-09-24
Device Description
ALLEGRETTO WAVE EYE-Q EXCIMER
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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LZS | Excimer Laser System | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41176 | Laser application software | An individual software program or group of programs, routines or algorithms intended to add specific computer assisted display, processing and/or analysis capabilities to a laser for storing, processing, and managing electronic information/data used during a treatment with a laser. It is typically installed in a laser and/or interfaced with an ordinary computer (e.g., tabletop, laptop) which displays the data. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00380659908170 | GS1 |
Customer Contacts
- Phone
- +1(800)-862-5266
- [email protected]