NovaPlug 2cm x 1cm NA2200

GUDID 00813909011462

Collagen wound dressing

NOVABONE PRODUCTS, LLC

General oral wound dressing, animal-derived

• Primary Device ID: 00813909011462
• NIH Device Record Key: 2a4eb39a-a44d-4ef2-8833-1a1bb6e1c87f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovaPlug 2cm x 1cm
• Version Model Number: NA2200
• Catalog Number: NA2200
• Company DUNS: 828813290
• Company Name: NOVABONE PRODUCTS, LLC
• Device Count: 10
• 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: 2 Centimeter
• Length: 2 Centimeter
• Length: 2 Centimeter
• Length: 2 Centimeter
• Outer Diameter: 1 Centimeter
• Length: 2 Centimeter
• Outer Diameter: 1 Centimeter
• Length: 2 Centimeter
• Outer Diameter: 1 Centimeter
• Length: 2 Centimeter
• Outer Diameter: 1 Centimeter
• Length: 2 Centimeter
• Outer Diameter: 1 Centimeter
• Length: 2 Centimeter
• Outer Diameter: 1 Centimeter
• Length: 2 Centimeter
• Outer Diameter: 1 Centimeter
• Length: 2 Centimeter
• Outer Diameter: 1 Centimeter
• Length: 2 Centimeter
• Outer Diameter: 1 Centimeter
• Length: 2 Centimeter
• Outer Diameter: 1 Centimeter
• Length: 2 Centimeter
• Outer Diameter: 1 Centimeter
• Length: 2 Centimeter
• Outer Diameter: 1 Centimeter
• Length: 2 Centimeter
• Outer Diameter: 1 Centimeter
• Length: 2 Centimeter
• Outer Diameter: 1 Centimeter
• Length: 2 Centimeter
• Outer Diameter: 1 Centimeter
• Length: 2 Centimeter
• Outer Diameter: 1 Centimeter
• Length: 2 Centimeter
• Outer Diameter: 1 Centimeter
• Length: 2 Centimeter
• Outer Diameter: 1 Centimeter
• Length: 2 Centimeter
• Outer Diameter: 1 Centimeter
• Length: 2 Centimeter
• Outer Diameter: 1 Centimeter
• Length: 2 Centimeter
• Outer Diameter: 1 Centimeter
• Length: 2 Centimeter
• Outer Diameter: 1 Centimeter
• Length: 2 Centimeter
• Outer Diameter: 1 Centimeter
• Length: 2 Centimeter

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
• 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	00813909010465 [Unit of Use]
GS1	00813909011462 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142712

FDA Product Code

• KGN: Dressing, Wound, Collagen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-03-09

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• 00813909013145 - IRM - 5.0cc: 2024-11-26 Synthetic bone void filler for orthopedic applications
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• 00813909012995 - Putty MIS System 10.0cc: 2024-08-29 Synthetic bone void filler for orthopedic applications
• 00813909013091 - Putty MIS System 10.0cc: 2024-08-29 Synthetic bone void filler for orthopedic applications