DEVICE: Centurion (00380657517626)

Device Identifier (DI) Information

Centurion
8065751762
In Commercial Distribution

Alcon Laboratories, Inc.
00380657517626
GS1

1
008018525 *Terms of Use
Centurion Vision System Footswitch
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Foot-switch, electrical An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable 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 [?]
K121555 000
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Sterilization

No
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
No Device Sizes
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Device Record Status

ee76cc99-59db-4c26-a299-3729168f1604
July 06, 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
No Package DIs found
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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)

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No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

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