FDA UDI
In Commercial Distribution
🇺🇸 United States
WAVENET
DI: 00380650004567
·
Model: 8065000456
·
Alcon Laboratories, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- WAVENET
- Primary DI
- 00380650004567
- Version / Model
- 8065000456
- Company Name
- Alcon Laboratories, Inc.
- Labeler DUNS
- 008018525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-08
- Public Version
- 4
- Public Version Date
- 2022-09-23
- Public Version Status
- Update
- Public Device Record Key
- d380e989-d255-4f92-9ae8-4b15ef065011
Device Description
WAVENET PLANNING SOFTWARE
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 |
|---|---|---|---|---|
| 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 | 00380650004567 | GS1 |
Customer Contacts
- Phone
- 1(800)-862-5266
- [email protected]