MaxxTape

GUDID 00813954023571

Dental Wound Dressing

COLLAGEN MATRIX, INC.

General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived General oral wound dressing, animal-derived

• Primary Device ID: 00813954023571
• NIH Device Record Key: 048d1b57-2138-4a0e-8008-2e20ec4a33ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MaxxTape
• Version Model Number: XTAPE
• Company DUNS: 176262442
• Company Name: COLLAGEN MATRIX, INC.
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813954023571 [Unit of Use]
GS1	10813954023578 [Primary]

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: 2020-07-07
• Device Publish Date: 2020-06-02

Devices Manufactured by COLLAGEN MATRIX, INC.

• 10813954026135 - EvoBone Plug: 2024-04-05 Bone Graft Composite Plug
• 10813954026142 - EvoBone Plug: 2024-04-05 Bone Graft Composite Plug
• 00813954025254 - MatrixMem: 2024-03-20 Regenerative Collagen Dental Membrane 15mm x 20mm
• 00813954025261 - MatrixMem: 2024-03-20 Regenerative Collagen Dental Membrane 20mm x 30mm
• 00813954025278 - MatrixMem: 2024-03-20 Regenerative Collagen Dental Membrane 30mm x 40mm
• 00813954026046 - ASYN Puck: 2023-11-08 Moldable Bioactive Bone Graft
• 00813954026053 - ASYN Puck: 2023-11-08 Moldable Bioactive Bone Graft
• 00813954026060 - ASYN Strip: 2023-11-08 Moldable Bioactive Bone Graft