DEVICE: CONSTELLATION (00380657515400)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HQC | Unit, phacofragmentation |
HQE | Instrument, vitreous aspiration and cutting, ac-powered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
8efc69c4-2344-4865-a89d-87db062fd38b
March 29, 2018
2
September 24, 2016
March 29, 2018
2
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)862-5266
web.masterus@alcon.com
web.masterus@alcon.com