Myriad Meshed Expandable Bioscaffold

GUDID 09421908222171

Myriad Meshed™ Expandable Bioscaffold is a sterile, single use ovine forestomach-derived extracellular matrix intended to cover, protect, and provide a moist wound environment.

AROA BIOSURGERY LIMITED

Collagen wound matrix dressing

• Primary Device ID: 09421908222171
• NIH Device Record Key: 8bc44b38-c007-4633-9022-9c3c18bb96a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Myriad Meshed Expandable Bioscaffold
• Version Model Number: MS01FH1822
• Company DUNS: 594540572
• Company Name: AROA BIOSURGERY LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a clean and dry area

Device Identifiers

Device Issuing Agency	Device ID
GS1	09421908222171 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092096

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: 2024-12-04
• Device Publish Date: 2024-11-26

On-Brand Devices [Myriad Meshed Expandable Bioscaffold]

• 09421908222171: Myriad Meshed™ Expandable Bioscaffold is a sterile, single use ovine forestomach-derived extra
• 09421908222164: Myriad Meshed™ Expandable Bioscaffold is a sterile, single use ovine forestomach-derived extra