Identity
- Trade Name
- OmniPore EUDAMEDOmniPore Surgical Implant FDA UDI
- Generic Name
- Polyethylene craniofacial tissue reconstructive material FDA UDI
- Device Name
- Design Y™ Malar - Small - Right EUDAMEDFDA UDI
- Model / Reference
- OP9513 EUDAMEDFDA UDI
- Description
- Design Y™ Malar - Small - Right FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855421005567 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00855421005567 EUDAMED
- 510(k) Number
- K123908 FDA UDI
- FDA Product Code
- KKY FDA UDI
- EMDN Code
- P010102 ZYGOMATIC PROSTHESES EUDAMED
- GMDN Term
- Polyethylene craniofacial tissue reconstructive material FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.3500 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Malar prosthesis
OmniPore by Matrix Surgical Holdings, LLC dba Matrix Surgical USA — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Malar prosthesis.
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- Conform™ Midfacial — Implantech Associates, Inc. · Class II
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- 900-014 Profile Malar Sizer Set — Implantech Associates, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00855421005567 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- EUDAMED SRN
- US-MF-000018643
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 0966ab82-288f-49fe-87f9-ce4e870fab8e 61 fields · synced Jul 10, 2026
- FDA UDI 170ee09b-c809-41a8-9615-bc3bcf016b90 34 fields · synced May 30, 2026