BioPlug BioHorizons - 20mm x 10mm BH2200

GUDID 00813909010250

Collagen wound dressing

NOVABONE PRODUCTS, LLC

General oral wound dressing, animal-derived

• Primary Device ID: 00813909010250
• NIH Device Record Key: dbdc99e2-2960-4000-9058-97aa68247a89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioPlug BioHorizons - 20mm x 10mm
• Version Model Number: BH2200
• Catalog Number: BH2200
• 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: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Length: 20 Millimeter
• Width: 10 Millimeter
• Length: 20 Millimeter
• Width: 10 Millimeter
• Length: 20 Millimeter
• Width: 10 Millimeter
• Length: 20 Millimeter
• Width: 10 Millimeter
• Length: 20 Millimeter
• Width: 10 Millimeter
• Length: 20 Millimeter
• Width: 10 Millimeter
• Length: 20 Millimeter
• Width: 10 Millimeter
• Length: 20 Millimeter
• Width: 10 Millimeter
• Length: 20 Millimeter
• Width: 10 Millimeter
• Length: 20 Millimeter
• Width: 10 Millimeter
• Length: 20 Millimeter
• Width: 10 Millimeter
• Length: 20 Millimeter
• Width: 10 Millimeter
• Length: 20 Millimeter
• Width: 10 Millimeter
• Length: 20 Millimeter
• Width: 10 Millimeter
• Length: 20 Millimeter
• Width: 10 Millimeter
• Length: 20 Millimeter
• Width: 10 Millimeter
• Length: 20 Millimeter
• Width: 10 Millimeter
• Length: 20 Millimeter
• Width: 10 Millimeter
• Length: 20 Millimeter
• Width: 10 Millimeter
• Length: 20 Millimeter
• Width: 10 Millimeter
• Length: 20 Millimeter
• Width: 10 Millimeter
• Length: 20 Millimeter
• Width: 10 Millimeter
• Length: 20 Millimeter
• Width: 10 Millimeter
• Length: 20 Millimeter

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	00813909010250 [Primary]
GS1	00813909010533 [Unit of Use]

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: 2016-09-14

Devices Manufactured by NOVABONE PRODUCTS, LLC

• 00813909013763 - Putty Syringe 5.0cc: 2025-08-12 Synthetic bone void filler for orthopedic applications
• 00813909013770 - IRM - 2.5cc: 2025-08-12 Synthetic bone void filler for orthopedic applications
• 00813909013787 - IRM - 5.0cc: 2025-08-12 Synthetic bone void filler for orthopedic applications
• 00813909010328 - Dental Porous Morsels 2x0.5g: 2025-07-25 Synthetic bone void filler for dental applications
• 00813909013756 - Dental Porous Morsels 2x1.5g: 2025-07-25 Synthetic bone void filler for dental applications
• 00813909013701 - Bioactive Strip 10.0cc Long: 2025-07-17 Synthetic bone void filler for orthopedic applications
• 00813909013718 - IRM - 2.5cc: 2025-07-17 Synthetic bone void filler for orthopedic applications
• 00813909013725 - IRM - 5.0cc: 2025-07-17 Synthetic bone void filler for orthopedic applications