Myriad Matrix™ Restore Restorative Bioscaffold

GUDID 09421908222416

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.

AROA BIOSURGERY LIMITED

Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

• Primary Device ID: 09421908222416
• NIH Device Record Key: 0bd30024-0e55-464e-bb4e-b03cdea9f344
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Myriad Matrix™ Restore Restorative Bioscaffold
• Version Model Number: SR02LG006R
• Company DUNS: 594540572
• Company Name: AROA BIOSURGERY LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Myriad Matrix Restore should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Myriad Matrix Restore should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Myriad Matrix Restore should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Myriad Matrix Restore should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Myriad Matrix Restore should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Myriad Matrix Restore should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Myriad Matrix Restore should be stored at room temperature in a clean and dry area.
• Special Storage Condition, Specify: Between 0 and 0 *Myriad Matrix Restore should be stored at room temperature in a clean and dry area.

Device Identifiers

Device Issuing Agency	Device ID
GS1	09421908222416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162461

FDA Product Code

• KGN: Wound dressing with animal-derived material(s)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-09
• Device Publish Date: 2026-01-30

On-Brand Devices [Myriad Matrix™ Restore Restorative Bioscaffold]

• 09421908222454: Myriad Matrix Restore is an intact extracellular matrix (ECM) derived from ovine (sheep) foresto
• 09421908222447: Myriad Matrix Restore is an intact extracellular matrix (ECM) derived from ovine (sheep) foresto
• 09421908222430: Myriad Matrix Restore is an intact extracellular matrix (ECM) derived from ovine (sheep) foresto
• 09421908222423: Myriad Matrix Restore is an intact extracellular matrix (ECM) derived from ovine (sheep) foresto
• 09421908222416: Myriad Matrix Restore is an intact extracellular matrix (ECM) derived from ovine (sheep) foresto
• 09421908222409: Myriad Matrix Restore is an intact extracellular matrix (ECM) derived from ovine (sheep) foresto
• 09421908222393: Myriad Matrix Restore is an intact extracellular matrix (ECM) derived from ovine (sheep) foresto