DEVICE: Constellation, Ultravit, TotalPlus, Engauge (00380657510658)

Device Identifier (DI) Information

Constellation, Ultravit, TotalPlus, Engauge
8065751065
In Commercial Distribution

Alcon Laboratories, Inc.
00380657510658
GS1

1
008018525 *Terms of Use
Constellation Vision System 5000 CPM UltraVit Probe Straight Endoilluminator 23 GA TotalPlus Combined Procedure Pak Engauge RFID 1.1 mm Tipless Anterior Kit
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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Product Code Product Code Name
HQE Instrument, vitreous aspiration and cutting, ac-powered
HQC Unit, phacofragmentation
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 23 Gauge
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Device Record Status

217ad57d-6081-428b-a2ec-1400644e69e0
March 29, 2018
2
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10380657510655 6 00380657510658 In Commercial Distribution Box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(800)862-5266
web.masterus@alcon.com
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