DuraGen Secure Dural Regeneration Matrix DRM1013

GUDID M269DRM10131

DuraGen Secure Dural Regeneration Matrix is an absorbable implant for the repair of dural defects. DuraGen Secure Dural Regeneration Matrix is an easy to handle, soft, pliable, non-friable, porous collagen matrix with an anti-migration layer (hydroxypropyl metlhycellulose (HPMC)) that, when used as directed, reduces the risk of product migration or displacement, e.g. during irrigation. DuraGen Secure Dural Regeneration Matrix is supplied sterile, non-pyrogenic, and in a variety of sizes for single-use.

Integra Lifesciences Corporation

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• Primary Device ID: M269DRM10131
• NIH Device Record Key: 6002c3c3-82c5-45d4-ab0d-751f02ab1c6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuraGen Secure Dural Regeneration Matrix
• Version Model Number: DRM1013
• Catalog Number: DRM1013
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• 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: true
• 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
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• Email: custsvcnj@integralife.com
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• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

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Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780032496 [Primary]
HIBCC	M269DRM10131 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120600

FDA Product Code

• GXQ: Dura Substitute

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: 2020-07-16
• Device Publish Date: 2015-07-31

On-Brand Devices [DuraGen Secure Dural Regeneration Matrix]

• M269DRM10331: DuraGen Secure Dural Regeneration Matrix is an absorbable implant for the repair of dural defect
• M269DRM10221: DuraGen Secure Dural Regeneration Matrix is an absorbable implant for the repair of dural defect
• M269DRM10131: DuraGen Secure Dural Regeneration Matrix is an absorbable implant for the repair of dural defect
• M269DRM10111: DuraGen Secure Dural Regeneration Matrix is an absorbable implant for the repair of dural defect