DEVICE: MEDPOR (07613252086390)

Device Identifier (DI) Information

MEDPOR
9857
In Commercial Distribution
9857
Stryker Leibinger GmbH & Co. KG
07613252086390
GS1

1
316153956 *Terms of Use
FLEXBLOCK? TF2 - Small Left
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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?
33310 Polyethylene craniofacial tissue reconstructive material
A sterile implantable device intended to support, contour, and provide structure for the craniofacial anatomy (i.e., head and face including the chin, cheeks, nose, eye sockets and ears) during reconstructive and plastic surgery procedures. It is typically a high-density polyethylene (PE) material with an interconnecting pore structure that supports tissue ingrowth. The device is available in blocks, sheets, wedges and spheres that can be cut by the surgeon to meet the patient's specific needs. 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
Length: 78.0 Millimeter
Device Size Text, specify: Thickness: 18.0 Millimeter
Height: 61.0 Millimeter
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Device Record Status

ae8d72bf-a3a1-49a4-a604-7d7502b7df07
October 12, 2020
4
September 24, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
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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