AccessGUDID - DEVICE: Myriad Matrix™ Soft Tissue Bioscaffold (09421906017663)

GUDID

Device Identifier (DI) Information

Brand Name: Myriad Matrix™ Soft Tissue Bioscaffold
Version or Model: SR02LG0505US
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AROA BIOSURGERY LIMITED

Primary DI Number: 09421906017663
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 594540572 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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
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

FDA Product Code

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Product Code	Product Code Name
KGN	Dressing, Wound, Collagen
FTM	Mesh, Surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162461	000
K171231	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Myriad Matrix should be stored at room temperature in a clean and dry area.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 5 x 5 cm, 2 Layer

Device Record Status

Public Device Record Key: 9377dae0-4556-420f-82dd-e6b9ba3b8c7f
Public Version Date: October 29, 2025
Public Version Number: 10
DI Record Publish Date: March 23, 2022