FDA UDI
In Commercial Distribution
🇺🇸 United States
Centurion
DI: 00380657517633
·
Model: 8065751763
·
Alcon Laboratories, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Centurion
- Primary DI
- 00380657517633
- Version / Model
- 8065751763
- Company Name
- Alcon Laboratories, Inc.
- Labeler DUNS
- 008018525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2022-01-24
- Public Version Status
- Update
- Public Device Record Key
- eac116fa-7a35-404e-aa72-ef160d64fdec
Device Description
Centurion vision 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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| HQC | Unit, phacofragmentation | Ophthalmic | 886.4670 | 2 |
| HQE | Instrument, vitreous aspiration and cutting, ac-powered | Ophthalmic | 886.4150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17596 | Phacoemulsification system generator | A mains electricity (AC-powered) ophthalmic device that generates the energy (e.g., ultrasonic, piezoelectric) in a cataract extraction system. The energy is delivered through a handpiece tip, which is introduced through an incision made in the lens capsule, to perform phacoemulsification (a procedure for the liquefying and removal of the opaque lens nucleus in cataract surgery). This device will typically be activated by the surgeon using a foot control and provide or support the irrigation/suction systems needed for the removal of debris. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00380657517633 | GS1 |
Customer Contacts
- Phone
- +1(800)862-5266
- [email protected]