DuraGen Plus™ Dural Regeneration Matrix DP1045
GUDID 10381780023470
DuraGen Plus™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects. DuraGen Plus™ is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen Plus™ 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 | 10381780023470 |
| NIH Device Record Key | 10fa02c6-9a23-4bf0-b17b-c7dd551cc272 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DuraGen Plus™ Dural Regeneration Matrix |
| Version Model Number | DP1045 |
| Catalog Number | DP1045 |
| 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 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com | |
| Phone | +1(800)654-2873 |
| custsvcnj@integralife.com |
Device Dimensions
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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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 | 10381780023470 [Primary] |
| HIBCC | M269DP10451 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K032693
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 Plus™ Dural Regeneration Matrix]
| 30381780070942 | DuraGen Plus™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects. |
| 30381780070935 | DuraGen Plus™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects. |
| 30381780070928 | DuraGen Plus™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects. |
| 30381780070911 | DuraGen Plus™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects. |
| 10381780023487 | DuraGen Plus™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects. |
| 10381780023470 | DuraGen Plus™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects. |
| 10381780023463 | DuraGen Plus™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects. |
| 10381780023456 | DuraGen Plus™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects. |
| 10381780023449 | DuraGen Plus™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects. |
| 10381780023432 | DuraGen Plus™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects. |
Trademark Results [DuraGen Plus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DURAGEN PLUS 76552853 2977756 Live/Registered |
INTEGRA LIFESCIENCES CORPORATION 2003-10-20 |
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