DEVICE: Alcon (00380657518005)

Device Identifier (DI) Information

Alcon
8065751800
In Commercial Distribution

Alcon Laboratories, Inc.
00380657518005
GS1

1
008018525 *Terms of Use
23 Ga 6mm Valved Trocar Cannula Entry System, 1 ct
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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 cannulation set, single-use A collection of devices used to provide an ocular working channel (i.e., an entry port in the eye for ophthalmic instrument access) through the sclera for posterior segment ophthalmic surgery. It typically consists of metal cannulae, and a trocar or blade inserted through a cannula to perform tissue incision enabling cannula insertion. It may also include a plug for the temporary closure of the cannula and tubing for the infusion of fluids. This is a single-use device.
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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

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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
Length: 6 Millimeter
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Device Record Status

791953a1-93a5-4008-a12d-6fb1c2b8c7fe
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
10380657518002 12 00380657518005 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

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Yes
No
Yes
No
No CLOSE

Customer Contact

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