Myriad Morcells™

GUDID 09421906017977

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: 09421906017977
• NIH Device Record Key: c1c54e7f-3a0e-47be-ba35-915ea21be282
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Myriad Morcells™
• Version Model Number: PW02NA0050
• 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

Device Dimensions

• Weight: 50 Milligram
• Weight: 50 Milligram
• Weight: 50 Milligram
• Weight: 50 Milligram
• Weight: 50 Milligram
• Weight: 50 Milligram
• Weight: 50 Milligram
• Weight: 50 Milligram
• Weight: 50 Milligram
• Weight: 50 Milligram
• Weight: 50 Milligram
• Weight: 50 Milligram
• Weight: 50 Milligram
• Weight: 50 Milligram
• Weight: 50 Milligram
• Weight: 50 Milligram
• Weight: 50 Milligram
• Weight: 50 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	09421906017977 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200502

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: 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