DEVICE: Engauge (00380657511853)
Device Identifier (DI) Information
Engauge
8065751185
In Commercial Distribution
Alcon Laboratories, Inc.
8065751185
In Commercial Distribution
Alcon Laboratories, Inc.
25 GA Wide Angle Endoilluminator
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
34125 | Vitrectomy system handpiece |
A holder for a detachable, micro-cutting tip that converts the energy (e.g., ultrasonic, piezoelectric) produced by a system generator into a mechanical oscillating-cutting action to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. This device will typically be activated by the surgeon using a foot control and provide or support the irrigation/suction systems needed to supply replacement fluid and remove debris. The handpiece is typically designed in the form of a pen or pencil, and connected to the generator via a cable. This is a reusable device intended to be sterilized prior to use.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HQC | Unit, phacofragmentation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 25 Gauge |
Device Record Status
f2bf8a6d-8afe-4147-978c-2c1cb4abfb95
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 |
---|---|---|---|---|---|
10380657511850 | 12 | 00380657511853 | In Commercial Distribution | Box |
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