DEVICE: Alcon Grieshaber CONSTELLATION (07612717071391)

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Device Identifier (DI) Information

Alcon Grieshaber CONSTELLATION
725.03

Alcon Laboratories, Inc.
07612717071391
GS1
1
CONSTELLATION Pneumatic Handpiece DSP
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
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
Ophthalmic surgical instrument handle, pneumatic A sterile, hand-held, pneumatically-powered device designed to hold and operate a compatible ophthalmic surgical instrument tip (e.g., scissors, forceps). It is typically in the form of a conventional handle with a connector that secures the inserted tip, and has a pneumatic feedline (tubing) that connects to a parent device with gas source; when gas is supplied to the handle, typically using a foot-switch, a mechanism is activated to operate the inserted tip (e.g., opens and closes blades). It is typically used for surgery in the anterior or the posterior segment to cut, grasp, and manipulate eye tissue. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
HQC Unit, Phacofragmentation
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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
No Device Sizes
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Device Status

In Commercial Distribution
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
17612717071398 6 07612717071391 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
Yes
No CLOSE

Customer Contact

[?]
+18008625266
Web.masterus@alcon.com
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