DEVICE: MEDPOR (07613252084822)

Device Identifier (DI) Information

MEDPOR
83004
In Commercial Distribution
83004
Stryker Leibinger GmbH & Co. KG
07613252084822
GS1

1
316153956 *Terms of Use
Midface Rim-Right
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
45228 Malar prosthesis
An implantable device designed to augment or maintain the soft-tissue anatomy of the malar area (cheek). The device is typically a solid elastomer (e.g., silicone) available in several shapes and sizes for subdermal implantation in the malar area for cosmetic or reconstructive purposes following traumatic or disease/congenital deformation. This is a single-use device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
FWP PROSTHESIS, CHIN, INTERNAL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K922489 000
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

[?]
Size Type Text
Device Size Text, specify: Thickness: 3.0 Millimeter
Width: 28.0 Millimeter
Length: 47.0 Millimeter
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Device Record Status

b9494a2a-dfa2-4516-884e-08daf5df3c44
October 12, 2020
4
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

[?]
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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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