Cohealyx™ BDCDM1020-5

GUDID 10813954026630

Collagen Dermal Matrix

COLLAGEN MATRIX, INC.

Collagen wound matrix dressing

• Primary Device ID: 10813954026630
• NIH Device Record Key: c722fc60-a5ad-4490-958f-991854fa6b95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cohealyx™
• Version Model Number: BDCDM1020-5
• Catalog Number: BDCDM1020-5
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-833-462-8482
• Email: customerservice@avitamedical.com
• Phone: 1-833-462-8482
• Email: customerservice@avitamedical.com
• Phone: 1-833-462-8482
• Email: customerservice@avitamedical.com
• Phone: 1-833-462-8482
• Email: customerservice@avitamedical.com
• Phone: 1-833-462-8482
• Email: customerservice@avitamedical.com
• Phone: 1-833-462-8482
• Email: customerservice@avitamedical.com
• Phone: 1-833-462-8482
• Email: customerservice@avitamedical.com
• Phone: 1-833-462-8482
• Email: customerservice@avitamedical.com
• Phone: 1-833-462-8482
• Email: customerservice@avitamedical.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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Avoid excessive heat and humidity.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813954026633 [Primary]
GS1	10813954026630 [Package]; Contains: 00813954026633; Package: Box [5 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: 2024-12-31
• Device Publish Date: 2024-12-23

On-Brand Devices [Cohealyx™]

• 10813954026630: Collagen Dermal Matrix
• 10813954026623: Collagen Dermal Matrix
• 00813954026619: Collagen Dermal Matrix
• 00813954026602: Collagen Dermal Matrix
• 00813954026596: Collagen Dermal Matrix
• 00813954026589: Collagen Dermal Matrix
• 00813954026572: Collagen Dermal Matrix
• 00813954026565: Collagen Dermal Matrix