DEVICE: IDESIGN ADVANCED WAVESCAN STUDIO (05050474591912)

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Device Identifier (DI) Information

IDESIGN ADVANCED WAVESCAN STUDIO
G300
0110-2261
ABBOTT MEDICAL OPTICS INC.
05050474591912
GS1
1
IDESIGN ADVANCED WAVESCAN STUDIO US
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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
Ophthalmic refractometer, automated A mains electricity (AC-powered), automated, ophthalmic device designed to measure the refractive error of the eye (the inaccuracies of focusing of light upon the retina) by measuring how light is changed when it enters the patient's eye(s). A beam of light is emitted from the device into the patient's eye and reflected back out where it is detected and measured for sphere, cylinder and axis, as well as high order aberration measurements; typically measured in dioptres (the reciprocal of the focal length of the lens expressed in metres). Using this information, the device, also known as an aberrometer, will automatically calculate the lens prescription needed to correct the patient's vision.
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FDA Product Code

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Product Code Product Code Name
LZS Excimer laser system
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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
July 15, 2015

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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
No
No CLOSE

Customer Contact

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+1(877)266-4543
SAN-SURGICAL-ORDERS@AMO.ABBOTT.COM
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