INTEGRA Bilayer Matrix Wound Dressing BMW405

GUDID M269BMW4051

INTEGRA Bilayer Matrix Wound Dressing is an advanced woundcare device comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan and a semi-permeable polysiloxane (silicone) layer. The semi-permeable silicone membrane controls water vapor loss, provides a flexible adherent covering for the wound surface and adds increased tear strength to the device. The collagen-glycosaminoglycan biodegradable matrix provides a scaffold for cellular invasion and capillary growth.

Integra Lifesciences Corporation

Skin regeneration template, human-/animal-derived

• Primary Device ID: M269BMW4051
• NIH Device Record Key: 3f88f10a-a668-4b2d-ad56-b4fe789a4cbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTEGRA Bilayer Matrix Wound Dressing
• Version Model Number: BMW405
• Catalog Number: BMW405
• 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
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

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

Operating and Storage Conditions

• 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
• 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	00381780032253 [Unit of Use]
GS1	10381780032250 [Primary]
HIBCC	M269BMW4051 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021792

FDA Product Code

• FRO: Dressing, wound, drug

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: 2019-12-23
• Device Publish Date: 2015-09-23

On-Brand Devices [INTEGRA Bilayer Matrix Wound Dressing]

• M269BMW8101: INTEGRA Bilayer Matrix Wound Dressing is an advanced woundcare device comprised of a porous matr
• M269BMW4101: INTEGRA Bilayer Matrix Wound Dressing is an advanced woundcare device comprised of a porous matr
• 10381780032243: INTEGRA Bilayer Matrix Wound Dressing is an advanced woundcare device comprised of a porous matr
• M269BMW41011: INTEGRA Bilayer Matrix Wound Dressing is an advanced woundcare device comprised of a porous matr
• M269BMW40511: INTEGRA Bilayer Matrix Wound Dressing is an advanced woundcare device comprised of a porous matr
• M269BMW20211: INTEGRA Bilayer Matrix Wound Dressing is an advanced woundcare device comprised of a porous matr
• M269BMW4051: INTEGRA Bilayer Matrix Wound Dressing is an advanced woundcare device comprised of a porous matr
• M269BMW81011: INTEGRA Bilayer Matrix Wound Dressing is an advanced woundcare device comprised of a porous matr