DEVICE: SOVEREIGN COMPACT (05050474520936)

Device Identifier (DI) Information

SOVEREIGN COMPACT
OPO65
In Commercial Distribution
OPO65
ABBOTT MEDICAL OPTICS INC.
05050474520936
GS1

1
103021940 *Terms of Use
Box - 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

[?]

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

GMDN Preferred Term Name GMDN Definition
Surgical irrigation tubing set, reusable A collection of flexible, single-bore, external tubing intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to the site of surgical intervention; it is not intended to navigate through an anatomical lumen. The tubing typically includes associated items such as clamps, filters, spikes, and connectors; it may include an integrated manual pump (e.g., a squeeze bulb) to assist in channelling between the irrigation source and the point of application. Some types may have dual tubing to assist gastric lavage. This is a reusable device intended to be sterilized prior to use.
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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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FDA Premarket Submission

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

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
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

3b24da32-654a-49d1-a5d0-24bcee98ca7c
November 16, 2018
3
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)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(877)266-4543
JJV-US-SURGICALORDERS@ITS.JNJ.COM
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