Wound Matrix WM0123

GUDID 00813909012834

Collagen wound dressing

NOVABONE PRODUCTS, LLC

Collagen wound matrix dressing

• Primary Device ID: 00813909012834
• NIH Device Record Key: 298c28b6-f57e-48ea-aa5d-b2ecf63c2860
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wound Matrix
• Version Model Number: WM0123
• Catalog Number: WM0123
• Company DUNS: 828813290
• Company Name: NOVABONE PRODUCTS, LLC
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 3 Inch
• Width: 2 Inch
• Length: 3 Inch
• Width: 2 Inch
• Length: 3 Inch
• Width: 2 Inch
• Length: 3 Inch
• Width: 2 Inch
• Length: 3 Inch
• Width: 2 Inch
• Length: 3 Inch
• Width: 2 Inch
• Length: 3 Inch
• Width: 2 Inch
• Length: 3 Inch
• Width: 2 Inch
• Length: 3 Inch
• Width: 2 Inch
• Length: 3 Inch
• Width: 2 Inch
• Length: 3 Inch
• Width: 2 Inch
• Length: 3 Inch
• Width: 2 Inch
• Length: 3 Inch
• Width: 2 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813909012834 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220498

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: 2023-12-11
• Device Publish Date: 2023-12-01

On-Brand Devices [Wound Matrix]

• 00813909012858: Collagen wound dressing
• 00813909012841: Collagen wound dressing
• 00813909012834: Collagen wound dressing
• 00813909012827: Collagen wound dressing