DEVICE: MEDPOR (07613252088776)

Device Identifier (DI) Information

MEDPOR
9430
In Commercial Distribution
9430
Stryker Leibinger GmbH & Co. KG
07613252088776
GS1

1
316153956 *Terms of Use
Inferior Orbital Rim - Right
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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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
Orbital rim prosthesis A sterile implantable ocular device used to reconstruct the floor of the bony cavity that contains the eyeball and its associated muscles, vessels, and nerves, (i.e., the orbital floor and/or rim of the eye socket), and is intended to house an artificial eye. It may be constructed of one of a variety of materials, or a combination, including stainless steel, titanium (Ti), titanium alloy, or flexible mesh alloplastics. It is an aspherical orbital volume replacement prosthesis that will typically have a spongy outer surface (e.g., reinforced with surgical mesh) designed to encourage tissue attachment.
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FDA Product Code

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Product Code Product Code Name
FWP PROSTHESIS, CHIN, INTERNAL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

Yes
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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
Device Size Text, specify: Thickness: 3.2 Millimeter
Height: 18.0 Millimeter
Length: 43.0 Millimeter
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Device Record Status

b3c1b56c-8a6b-4119-b5d3-936c5cf53fe0
March 29, 2018
2
September 24, 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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Yes
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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