DuraGen Plus™ Spinal Matrix 51100213

GUDID 10381780070726

DuraGen Plus Dural Regeneration Matrix- Spinal Matrix is an absorbable implant for repair of dural defects. DuraGen Plus Dural Regeneration Matrix-Spinal Matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen Plus Dural Regeneration Matrix-Spinal Matrix is two 1 inch x 3 inch (2.5cm x 7.5xm) dural regeneration matrices supplied sterile, non-pyrogenic, for single use in double peel packages.

Integra Lifesciences Corporation

Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine

• Primary Device ID: 10381780070726
• NIH Device Record Key: 7fc71b32-47dd-4305-a16c-09e5b49fca8a
• Commercial Distribution Discontinuation: 2015-09-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DuraGen Plus™ Spinal Matrix
• Version Model Number: 51100213
• Catalog Number: 51100213
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• Device Count: 2
• 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
• 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

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00381780070729 [Unit of Use]
GS1	10381780070726 [Primary]
HIBCC	M269511002131 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092388

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: 5
• Public Version Date: 2020-09-22
• Device Publish Date: 2015-09-22

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