DEVICE: SOVEREIGN COMPACT (05050474520936)

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Device Identifier (DI) Information

SOVEREIGN COMPACT
OPO65
OPO65
ABBOTT MEDICAL OPTICS INC.
05050474520936
GS1
1
SOVEREIGN COMPACT REUSABLE 5-PACK
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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 irrigation/aspiration pump A mains electricity (AC-powered), ophthalmic device used to irrigate the area pertaining to the eye and eye cavity with a fluid to provide a flushing effect during ophthalmic surgery and also to aspirate by drawing liquid out of the pertinent area. It will be used for the removal of, e.g., debris, tissue or fluids from the site, and will assist the operator by keeping the site cleared and improving the field of observation. It is commonly used during cataract operations and can generate a positive and/or negative pressure with its pumping systems and is used together with compatible instruments. This device must operate at extremely low pressure to avoid inadvertent damage to the site.
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FDA Product Code

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Product Code Product Code Name
KYG DEVICE, IRRIGATION, OCULAR SURGERY
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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 02, 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
15050474520933 5 05050474520936 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)

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Yes
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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