Identity
- Trade Name
- Myriad Matrix™ Soft Tissue Bioscaffold FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI
- Device Name
- Myriad Matrix™ is an intact extracelluar matrix (ECM) derived from ovine (sheep) forestomach tissue. This advanced ECM scaffold is non-reconstituted collagen, thus it retains the innate biological structure and function of the native ECM associated macromolecules including elastin, fibronectin, glycosaminoglycans and laminin. Myriad Matrix transforms into a soft conforming sheet, which is incorporated into the surrounding tissue over time. The device is supplied sterile and dry in a variety of sizes and thicknesses, which can be trimmed to size or applied whole to meet the individual patient's needs. FDA UDI
- Model / Reference
- SR03LG0505US FDA UDI
- Description
- Myriad Matrix™ is an intact extracelluar matrix (ECM) derived from ovine (sheep) forestomach tissue. This advanced ECM scaffold is non-reconstituted collagen, thus it retains the innate biological structure and function of the native ECM associated macromolecules including elastin, fibronectin, glycosaminoglycans and laminin. Myriad Matrix transforms into a soft conforming sheet, which is incorporated into the surrounding tissue over time. The device is supplied sterile and dry in a variety of sizes and thicknesses, which can be trimmed to size or applied whole to meet the individual patient's needs. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09421906017656 FDA UDI
- FDA Product Code
- KGN FDA UDIFTM FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Animal-derived wound matrix dressingExtra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Myriad Matrix™ Soft Tissue Bioscaffold by Aroa Biosurgery — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial.
- Biodesign — COOK BIOTECH INCORPORATED · Class II
- Strattice Reconstructive Tissue Matrix — LIFECELL CORP · Class II
- Meso BioMatrix® Acellular Peritoneum Matrix — DSM BIOMEDICAL, INC. · Class II
- Strattice Reconstructive Tissue Matrix — LIFECELL CORP · Class II
- Rotation Medical Reconstituted Collagen Scaffold - Arthroscopic, Medium — Smith & Nephew, Inc. · Class II
- Permacol — SOFRADIM PRODUCTION · Class II
- XENMATRIX — Davol Inc. · Class II
- Gentrix® — ACELL, INC. · Class II
Cleared under the same submission
K162461 also covers:
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery
K171231 also covers:
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery
- Myriad Matrix™ Soft Tissue Bioscaffold — Aroa Biosurgery
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aroa Biosurgery
Sources (1)
- FDA UDI 3cd6bc86-df0c-4cf7-9819-a9ac957fac03 36 fields · synced May 30, 2026