NeoMatriX Wound Matrix FDSD0103

GUDID 00860008106582

NeoMatriX Wound Matrix is a sterile, wound dressing fabricated from the dermal extracellular matrix of axolotl. NeoMatriX is provided as sheets of various sizes for placement on wound beds to help manage the wound environment. This device is terminally sterilized using gamma irradiation. NeoMatriX wound matrix provides an adherent covering that protects the wound from the environment. The device is intended for one time use.

NEXTGEN BIOLOGICS INC

Collagen wound matrix dressing

• Primary Device ID: 00860008106582
• NIH Device Record Key: 77a8851a-e593-4e2c-89e9-0ed3101ae12b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoMatriX Wound Matrix
• Version Model Number: FDSD0103
• Catalog Number: FDSD0103
• Company DUNS: 083272045
• Company Name: NEXTGEN BIOLOGICS INC
• 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

Customer Support Contacts

• Phone: (800) 209-7190
• Email: jltoothman@nextgenbiologics.com
• Phone: (800) 209-7190
• Email: jltoothman@nextgenbiologics.com
• Phone: (800) 209-7190
• Email: jltoothman@nextgenbiologics.com
• Phone: (800) 209-7190
• Email: jltoothman@nextgenbiologics.com
• Phone: (800) 209-7190
• Email: jltoothman@nextgenbiologics.com
• Phone: (800) 209-7190
• Email: jltoothman@nextgenbiologics.com
• Phone: (800) 209-7190
• Email: jltoothman@nextgenbiologics.com
• Phone: (800) 209-7190
• Email: jltoothman@nextgenbiologics.com
• Phone: (800) 209-7190
• Email: jltoothman@nextgenbiologics.com
• Phone: (800) 209-7190
• Email: jltoothman@nextgenbiologics.com
• Phone: (800) 209-7190
• Email: jltoothman@nextgenbiologics.com
• Phone: (800) 209-7190
• Email: jltoothman@nextgenbiologics.com
• Phone: (800) 209-7190
• Email: jltoothman@nextgenbiologics.com
• Phone: (800) 209-7190
• Email: jltoothman@nextgenbiologics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860008106582 [Primary]

FDA Product Code

• KGN: Dressing, Wound, Collagen

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: 2024-10-24
• Device Publish Date: 2024-10-16