Myriad Ultra™ Reinforced BioScaffold – Permanent (PP) LP04PP1520

GUDID 09421906661880

Myriad Ultra ™ Reinforced Tissue Matrix is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and monofilament polypropylene colored with ([phathalocyaninato(2-)] copper). Myriad™ is intended for applications in plastic and reconstructive surgery or to cover, protect and provide a moist wound environment. The device may be fixed, via sutures, staples or tacks to surround the tissue if desired.

AROA BIOSURGERY LIMITED

Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite

• Primary Device ID: 09421906661880
• NIH Device Record Key: 1d00eec2-b3b9-4218-a3a2-e8044db472ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Myriad Ultra™ Reinforced BioScaffold – Permanent (PP)
• Version Model Number: LP04PP1520
• Catalog Number: LP04PP1520
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +6498693035
• Email: Minh.Lam@aroabio.com
• Phone: +6498693035
• Email: Minh.Lam@aroabio.com
• Phone: +6498693035
• Email: Minh.Lam@aroabio.com

Device Dimensions

• Width: 15 Centimeter
• Length: 20 Centimeter
• Width: 15 Centimeter
• Length: 20 Centimeter
• Width: 15 Centimeter
• Length: 20 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	09421906661880 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153632

FDA Product Code

• FTL: Mesh, Surgical, Polymeric

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: 2022-12-06
• Device Publish Date: 2022-11-28

On-Brand Devices [Myriad Ultra™ Reinforced BioScaffold – Permanent (PP)]

• 09421906661897: Myriad Ultra ™ Reinforced Tissue Matrix is a sterile bioscaffold composed of ovine (sheep) der
• 09421906661880: Myriad Ultra ™ Reinforced Tissue Matrix is a sterile bioscaffold composed of ovine (sheep) der