Symphony™ Proliferative Bioscaffold

GUDID 09421905067096

Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of glycosaminoglycans between sheets of ovine forestomach-derived extracellular matrix.

AROA BIOSURGERY LIMITED

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• Primary Device ID: 09421905067096
• NIH Device Record Key: 3e182fa4-28bf-4f9b-9e20-d6acfaae3fa8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Symphony™ Proliferative Bioscaffold
• Version Model Number: CM04HA0202
• 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

Customer Support Contacts

• Phone: 877-627-6224
• Email: CustomerService@aroabio.com
• Phone: 877-627-6224
• Email: CustomerService@aroabio.com
• Phone: 877-627-6224
• Email: CustomerService@aroabio.com
• Phone: 877-627-6224
• Email: CustomerService@aroabio.com
• Phone: 877-627-6224
• Email: CustomerService@aroabio.com
• Phone: 877-627-6224
• Email: CustomerService@aroabio.com
• Phone: 877-627-6224
• Email: CustomerService@aroabio.com
• Phone: 877-627-6224
• Email: CustomerService@aroabio.com
• Phone: 877-627-6224
• Email: CustomerService@aroabio.com
• Phone: 877-627-6224
• Email: CustomerService@aroabio.com
• Phone: 877-627-6224
• Email: CustomerService@aroabio.com
• Phone: 877-627-6224
• Email: CustomerService@aroabio.com
• Phone: 877-627-6224
• Email: CustomerService@aroabio.com
• Phone: 877-627-6224
• Email: CustomerService@aroabio.com
• Phone: 877-627-6224
• Email: CustomerService@aroabio.com

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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	09421905067096 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200413

FDA Product Code

• KGN: Dressing, Wound, Collagen

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: 2020-12-23
• Device Publish Date: 2020-12-15

On-Brand Devices [Symphony™ Proliferative Bioscaffold]

• 09421905067102: Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of gly
• 09421905067096: Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of gly
• 09421905067072: Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of gly
• 09421907331584: Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of gly
• 09421907331577: Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of gly
• 09421907331560: Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of gly
• 09421907331553: Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of gly
• 09421907331546: Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of gly
• 09421907331539: Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of gly
• 09421907331522: Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of gly
• 09421907331515: Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of gly
• 09421907331508: Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of gly
• 09421907331492: Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of gly
• 09421907331485: Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of gly
• 09421907331478: Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of gly
• 09421907331461: Symphony™ is a sterile, single use wound dressing manufactured by incorporating a layer of gly