Myriad Morcells™

GUDID 09421906017908

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

• Primary Device ID: 09421906017908
• NIH Device Record Key: 003aa0b8-9bb6-4769-bf89-df2d71a838f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Myriad Morcells™
• Version Model Number: PW01NA0200
• 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: 200 Milligram
• Weight: 200 Milligram
• Weight: 200 Milligram
• Weight: 200 Milligram
• Weight: 200 Milligram
• Weight: 200 Milligram
• Weight: 200 Milligram
• Weight: 200 Milligram
• Weight: 200 Milligram
• Weight: 200 Milligram
• Weight: 200 Milligram
• Weight: 200 Milligram
• Weight: 200 Milligram
• Weight: 200 Milligram
• Weight: 200 Milligram
• Weight: 200 Milligram
• Weight: 200 Milligram
• Weight: 200 Milligram
• 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 Size Text, specify: 0

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09421906017908 [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