DEVICE: Myriad Matrix™ Restore Restorative Bioscaffold (09421908222430)
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Device Identifier (DI) Information
Myriad Matrix™ Restore Restorative Bioscaffold
SR02LG016S
In Commercial Distribution
AROA BIOSURGERY LIMITED
SR02LG016S
In Commercial Distribution
AROA BIOSURGERY LIMITED
Myriad Matrix Restore is an intact extracellular 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.
Device Characteristics
| MR Safe | |
| No | |
| Yes | |
| 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. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 60907 | Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial |
A bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. Disposable devices associated with implantation may be supplied with the mesh.
|
Active | true |
| 45023 | Animal-derived wound matrix dressing |
A bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| KGN | Wound dressing with animal-derived material(s) |
| FTM | Mesh, surgical |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K162461 | 000 |
| K171231 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Special Storage Condition, Specify: Myriad Matrix Restore should be stored at room temperature in a clean and dry area. |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: 4 x 4 cm, 2 Layer |
Device Record Status
67a00325-6393-4eb9-a613-9cc4579ab9ef
February 09, 2026
1
January 30, 2026
February 09, 2026
1
January 30, 2026
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 | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| 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