INTEGRA Matrix Wound Dressing 54055

GUDID M269540551

INTEGRA Matrix Wound Dressing is an advanced wound care device comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan. The collagen-glycosaminoglycan biodegradable matrix provides a scaffold for cellular invasion and capillary growth.

Integra Lifesciences Corporation

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• Primary Device ID: M269540551
• NIH Device Record Key: f9d9d4dc-a411-4c22-8ef3-c2008aefa592
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTEGRA Matrix Wound Dressing
• Version Model Number: 54055
• Catalog Number: 54055
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• Device Count: 5
• 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(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch
• Length: 12.5 Centimeter
• Width: 10 Centimeter
• Length: 5 Inch
• Width: 4 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store Flat
• Handling Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00381780032338 [Unit of Use]
GS1	10381780032335 [Primary]
HIBCC	M269540551 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022127

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: 4
• Public Version Date: 2020-08-28
• Device Publish Date: 2015-09-23

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• M269541051: INTEGRA Matrix Wound Dressing is an advanced wound care device comprised of a porous matrix of c
• M269540551: INTEGRA Matrix Wound Dressing is an advanced wound care device comprised of a porous matrix of c
• M269520251: INTEGRA Matrix Wound Dressing is an advanced wound care device comprised of a porous matrix of c
• M269581011: INTEGRA Matrix Wound Dressing is an advanced wound care device comprised of a porous matrix of c
• M269541011: INTEGRA Matrix Wound Dressing is an advanced wound care device comprised of a porous matrix of c
• M269540511: INTEGRA Matrix Wound Dressing is an advanced wound care device comprised of a porous matrix of c
• M269520211: INTEGRA Matrix Wound Dressing is an advanced wound care device comprised of a porous matrix of c