PLENA WOUND DRESSING FOAM BDDWDF2040

GUDID 10813954027163

Collagen Dental Dressing

COLLAGEN MATRIX, INC.

General oral wound dressing, animal-derived

• Primary Device ID: 10813954027163
• NIH Device Record Key: 8e2885de-9472-43cb-b785-87b5524331ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PLENA WOUND DRESSING FOAM
• Version Model Number: BDDWDF2040
• Catalog Number: BDDWDF2040
• Company DUNS: 176262442
• Company Name: COLLAGEN MATRIX, 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: 1-844-862-7846
• Email: info@sweden-martina.com
• Phone: 1-844-862-7846
• Email: info@sweden-martina.com
• Phone: 1-844-862-7846
• Email: info@sweden-martina.com
• Phone: 1-844-862-7846
• Email: info@sweden-martina.com
• Phone: 1-844-862-7846
• Email: info@sweden-martina.com
• Phone: 1-844-862-7846
• Email: info@sweden-martina.com
• Phone: 1-844-862-7846
• Email: info@sweden-martina.com
• Phone: 1-844-862-7846
• Email: info@sweden-martina.com
• Phone: 1-844-862-7846
• Email: info@sweden-martina.com
• Phone: 1-844-862-7846
• Email: info@sweden-martina.com
• Phone: 1-844-862-7846
• Email: info@sweden-martina.com
• Phone: 1-844-862-7846
• Email: info@sweden-martina.com

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

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813954027166 [Primary]
GS1	10813954027163 [Package]; Contains: 00813954027166; Package: Box [10 Units]; In Commercial Distribution

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: 2025-07-24
• Device Publish Date: 2025-07-16

Devices Manufactured by COLLAGEN MATRIX, INC.

• 10813954026784 - SynOss Plug: 2025-09-15 Bone Graft Composite
• 10813954026791 - SynOss Plug: 2025-09-15 Bone Graft Composite
• 00813954027203 - Socket Repair Membrane: 2025-08-29 Absorbable Collagen Membrane
• 00813954027005 - PLENA Graft 0.5cc Syringe: 2025-08-11 Anorganic Bone Mineral in Syringe
• 00813954027111 - PLENA Graft 0.5cc Syringe: 2025-08-11 Anorganic Bone Mineral in Syringe
• 00813954027272 - Arthrex Nerve Conduit: 2025-08-04 Flexible Collagen Nerve Tube
• 00813954027289 - Arthrex Nerve Conduit: 2025-08-04 Flexible Collagen Nerve Tube
• 00813954027296 - Arthrex Nerve Conduit: 2025-08-04 Flexible Collagen Nerve Tube