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

• 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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