DEVICE: Alcon (00380657514489)

Device Identifier (DI) Information

Alcon
8065751448
In Commercial Distribution

Alcon Laboratories, Inc.
00380657514489
GS1

1
008018525 *Terms of Use
25 Gauge Entry System, Enhanced, 1 ea
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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 non-powered devices intended to be used to create a channel through the sclera for posterior segment ophthalmic surgery. It consists of metal cannulae, often with tubing, and includes additional ophthalmic instruments/devices intended to support the cannulation procedure (e.g., a trocar, plug, syringe, filter). 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: 25 Gauge
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Device Record Status

18e5c345-15af-4ca1-b601-e882c4c5d41a
July 24, 2018
3
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
10380657514486 12 00380657514489 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
No
No CLOSE

Customer Contact

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