Wound Matrix WM0145

GUDID 00813909012858

Collagen wound dressing

NOVABONE PRODUCTS, LLC

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: 00813909012858
• NIH Device Record Key: b956e45a-519b-4865-a045-61c119ada351
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wound Matrix
• Version Model Number: WM0145
• Catalog Number: WM0145
• 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: 5 Inch
• Width: 4 Inch
• Length: 5 Inch
• Width: 4 Inch
• Length: 5 Inch
• Width: 4 Inch
• Length: 5 Inch
• Width: 4 Inch
• Length: 5 Inch
• Width: 4 Inch
• Length: 5 Inch
• Width: 4 Inch
• Length: 5 Inch
• Width: 4 Inch
• Length: 5 Inch
• Width: 4 Inch
• Length: 5 Inch
• Width: 4 Inch
• Length: 5 Inch
• Width: 4 Inch
• Length: 5 Inch
• Width: 4 Inch
• Length: 5 Inch
• Width: 4 Inch
• Length: 5 Inch
• Width: 4 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	00813909012858 [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