DuraGen® Dural Graft Matrix ID3305

GUDID 30381780023603

DURAGEN 5 PK 3x3 DOM DuraGen® Dural Graft Matrix is an absorbable implant for repair of dura matter defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfirable, porous collagen matrix. DuraGen 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: 30381780023603
• NIH Device Record Key: 34409da6-f02d-42ca-8e3d-6e72656735f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuraGen® Dural Graft Matrix
• Version Model Number: ID3305
• Catalog Number: ID3305
• 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
• 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

• Device Size Text, specify: 0
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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780023609 [Primary]
GS1	30381780023603 [Package]; Contains: 10381780023609; Package: BOX [5 Units]; In Commercial Distribution
HIBCC	M269ID33051 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982180

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® Dural Graft Matrix]

• 10381780023616: DURAGEN 1 PK, 4x5 DOM DuraGen® Dural Graft Matrix is an absorbable implant for repair of dura m
• 30381780023603: DURAGEN 5 PK 3x3 DOM DuraGen® Dural Graft Matrix is an absorbable implant for repair of dura m
• 10381780023593: DURAGEN 1 PK 3x3 DOM DuraGen® Dural Graft Matrix is an absorbable implant for repair of dura ma
• 30381780023580: DURAGEN 5PK, 2x2 DOM DuraGen® Dural Graft Matrix is an absorbable implant for repair of dura ma
• 10381780023579: DURAGEN 1PK, 2x2 DOM DuraGen® Dural Graft Matrix is an absorbable implant for repair of dura ma
• 30381780023566: DURAGEN 5 PK, 1x3 DOM DuraGen® Dural Graft Matrix is an absorbable implant for repair of dura m
• 10381780023555: DURAGEN 1 PK, 1x3 DOM DuraGen® Dural Graft Matrix is an absorbable implant for repair of dura m
• 30381780023542: DURAGEN 5 PK, 1x1 DOM DuraGen® Dural Graft Matrix is an absorbable implant for repair of dura m
• 10381780023531: DURAGEN 1 PK, 1x1 DOM DuraGen® Dural Graft Matrix is an absorbable implant for repair of dura m