DuraGen Plus™ Dural Regeneration Matrix DP1033

GUDID 10381780023463

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

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Primary Device ID10381780023463
NIH Device Record Key4b3e6919-d247-4209-94c4-e8541de8d670
Commercial Distribution StatusIn Commercial Distribution
Brand NameDuraGen Plus™ Dural Regeneration Matrix
Version Model NumberDP1033
Catalog NumberDP1033
Company DUNS083171244
Company NameIntegra Lifesciences Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

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Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780023463 [Primary]
HIBCCM269DP10331 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXQDURA SUBSTITUTE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-09-22
Device Publish Date2015-09-22

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

30381780070942DuraGen Plus™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects.
30381780070935DuraGen Plus™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects.
30381780070928DuraGen Plus™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects.
30381780070911DuraGen Plus™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects.
10381780023487DuraGen Plus™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects.
10381780023470DuraGen Plus™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects.
10381780023463DuraGen Plus™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects.
10381780023456DuraGen Plus™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects.
10381780023449DuraGen Plus™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects.
10381780023432DuraGen 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
DURAGEN PLUS
76552853 2977756 Live/Registered
INTEGRA LIFESCIENCES CORPORATION
2003-10-20

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