DEVICE: CONSTELLATION (00380657509683)

Device Identifier (DI) Information

CONSTELLATION
8065750968
In Commercial Distribution

Alcon Laboratories, Inc.
00380657509683
GS1

1
008018525 *Terms of Use
CONSTELLATION REMOTE CONTROL
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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
Operating room equipment remote control A hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to control the functions of an operating table (e.g., orthopaedic operating table, ophthalmic operating table), lights, and/or cameras in the operating room (OR) from a distance via a connected cable or wirelessly [e.g., radio-frequency (RF), infrared (IR) transmission]. It is intended to be operated by the healthcare provider.
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FDA Product Code

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

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

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

b09ce4f9-a51d-4527-8208-b4f70bf7ce2f
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
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

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No
Yes
No
Yes
No CLOSE

Customer Contact

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