FDA UDI
In Commercial Distribution
🇺🇸 United States
CONSTELLATION
DI: 00380657530410
·
Model: 8065753041
·
Alcon Laboratories, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CONSTELLATION
- Primary DI
- 00380657530410
- Version / Model
- 8065753041
- Company Name
- Alcon Laboratories, Inc.
- Labeler DUNS
- 008018525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-16
- Public Version
- 1
- Public Version Date
- 2018-11-16
- Public Version Status
- New
- Public Device Record Key
- bb4c5526-d807-4165-8954-765fd80acd81
Device Description
CONSTELLATION TABLE TOP
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
- Yes
- 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 |
|---|---|---|---|---|
| HQE | Instrument, vitreous aspiration and cutting, ac-powered | Ophthalmic | 886.4150 | 2 |
| HQC | Unit, phacofragmentation | Ophthalmic | 886.4670 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45073 | Phacoemulsification/vitrectomy system generator | A mains electricity (AC-powered) ophthalmic device, that is a component of a system, that generates the energies (e.g., ultrasonic, piezoelectric, high frequency current) delivered through handpieces/tips that are introduced through an incision(s) made in the eye, for the purposes of performing combined phacoemulsification and/or vitrectomy (the removal and replacement of cataracts and/or the vitreous in anterior and posterior segment surgical procedures). It will typically be activated by the surgeon using a foot-switch and may include an irrigation/suction system for the removal of debris, a tamponade system (e.g., silicone and air), a diathermy device, and an intraocular illuminator. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00380657530410 | GS1 |
Customer Contacts
- Phone
- +1(800)862-5266
- [email protected]