DuraGen XS™ Dural Regeneration Matrix DXM1057

GUDID 10381780070993

DuraGenXS Matrix Dural Regeneration Matrix is an absorbable implant for repair of dural defects. DuraGenXS Matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGenXS Matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.

Integra Lifesciences Corporation

Dura mater graft, bovine

• Primary Device ID: 10381780070993
• NIH Device Record Key: 852beda0-5027-4181-ad16-6e1aad4f86ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuraGen XS™ Dural Regeneration Matrix
• Version Model Number: DXM1057
• Catalog Number: DXM1057
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780070993 [Primary]
HIBCC	M269DXM10571 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072207

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: 2020-09-22
• Device Publish Date: 2015-09-22

On-Brand Devices [DuraGen XS™ Dural Regeneration Matrix]

• 10381780070993: DuraGenXS Matrix Dural Regeneration Matrix is an absorbable implant for repair of dural defects.
• 10381780070986: DuraGenXS Matrix Dural Regeneration Matrix is an absorbable implant for repair of dural defects.
• 10381780070979: DuraGenXS Matrix Dural Regeneration Matrix is an absorbable implant for repair of dural defects.
• 10381780070962: DuraGenXS Matrix Dural Regeneration Matrix is an absorbable implant for repair of dural defects.
• 10381780070955: DuraGenXS Matrix Dural Regeneration Matrix is an absorbable implant for repair of dural defects.