Identity
- Trade Name
- OmniPore EUDAMEDOmniPore Surgical Implant FDA UDI
- Generic Name
- Polyethylene craniofacial tissue reconstructive material FDA UDI
- Device Name
- 3S™ Sheet EUDAMEDFDA UDI
- Model / Reference
- OP8312 EUDAMEDFDA UDI
- Description
- 3S™ Sheet FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00855421005062 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00855421005062 EUDAMED
- 510(k) Number
- K123908 FDA UDI
- FDA Product Code
- KKY FDA UDI
- EMDN Code
- P9099 IMPLANTABLE PROSTHETIC DEVICES - OTHER 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
OmniPore by Matrix Surgical Holdings, LLC dba Matrix Surgical USA — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-00855421005062 | 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 fb6525a6-16c8-4421-82c3-e38c15ce90c3 61 fields · synced Jul 11, 2026
- FDA UDI 408da340-de3b-450c-a537-f619ec1a5e3a 34 fields · synced May 30, 2026