DEVICE: Constellation, Ultravit, TotalPlus, EdgePlus (00380657516131)

Device Identifier (DI) Information

Constellation, Ultravit, TotalPlus, EdgePlus
8065751613
In Commercial Distribution

Alcon Laboratories, Inc.
00380657516131
GS1

1
008018525 *Terms of Use
Constellation Vision System 7500 CPM UltraVit Probe Straight Endoilluminator 23GA TotalPlus Vitrectomy Pak EdgePlus Blade Valved Entry System
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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
Ophthalmic surgical procedure kit, non-medicated, single-use A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not dedicated to a specific intraocular procedure (e.g., device implantation). It does not contain any pharmaceuticals. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
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

[?]
Size Type Text
Device Size Text, specify: 23 Gauge
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Device Record Status

c8149ccd-b2fd-427f-9fac-ac1cb2359a84
March 29, 2018
2
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10380657516138 6 00380657516131 In Commercial Distribution Box
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Secondary DI

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

[?]
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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