DEVICE: OmniPore Surgical Implant (00855421005093)
Device Identifier (DI) Information
OmniPore Surgical Implant
OP9542
In Commercial Distribution
MATRIX SURGICAL HOLDINGS, LLC
OP9542
In Commercial Distribution
MATRIX SURGICAL HOLDINGS, LLC
Enophthalmos Wedge - Regular - Right
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
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. 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.
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Active | true |
31038 | Nasal cartilage support implant, non-bioabsorbable |
A non-bioabsorbable device intended to be implanted beneath the skin of the nose (e.g., between the nasal mucosa and the cartilage) to augment or restore the cosmetic appearance and/or function of the nose, by providing structural support to the cartilage. It is a shaped device made of synthetic polymer materials (e.g., solid silicone rubber).
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K123908 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0c9004b2-6eaf-4cb1-9702-b378420f7f1c
March 05, 2024
2
April 23, 2020
March 05, 2024
2
April 23, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined