Myriad Morcells™

GUDID 09421906017939

Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen and is supplied as a sterile particulate.

AROA BIOSURGERY LIMITED

Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing

• Primary Device ID: 09421906017939
• NIH Device Record Key: 10aaf683-d5da-4770-add2-b82e17e89a24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Myriad Morcells™
• Version Model Number: PW02NA1000
• 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: false
• 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
• 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

• Weight: 1000 Milligram
• Weight: 1000 Milligram
• Weight: 1000 Milligram
• Weight: 1000 Milligram
• Weight: 1000 Milligram
• Weight: 1000 Milligram
• Weight: 1000 Milligram
• Weight: 1000 Milligram
• Weight: 1000 Milligram
• Weight: 1000 Milligram
• Weight: 1000 Milligram
• Weight: 1000 Milligram
• Weight: 1000 Milligram
• Weight: 1000 Milligram
• Weight: 1000 Milligram
• Weight: 1000 Milligram
• Weight: 1000 Milligram
• Weight: 1000 Milligram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	09421906017939 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200502

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: 2023-05-17
• Device Publish Date: 2023-05-09

On-Brand Devices [Myriad Morcells™]

• 09421905067928: Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen
• 09421905067911: Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen
• 09421906017977: Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen
• 09421906017960: Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen
• 09421906017953: Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen
• 09421906017946: Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen
• 09421906017939: Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen
• 09421906017922: Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen
• 09421906017915: Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen
• 09421906017908: Myriad Morcells™ is derived from an extracellular matrix primarily composed of ovine collagen