Suturable DuraGen™ Dural Regeneration Matrix DURS2291

GUDID 10381780023500

SUTURABLE DURAGEN, 1PK, 2x2 Suturable DuraGen™ Dural Regeneration Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened collagen component. Suturable DuraGen is supplied sterile, nonpyrogenic, for single use in double peel packages in a vairety of sizes. Suturable DuraGen may be applied using either onlay or suturing technique depending on clinical need and surgeon preference.

Integra Lifesciences Corporation

Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater graft, bovine Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant Dura mater biomatrix implant
Primary Device ID10381780023500
NIH Device Record Keye798847f-73ac-4cf0-8c67-e57ec7ebb448
Commercial Distribution StatusIn Commercial Distribution
Brand NameSuturable DuraGen™ Dural Regeneration Matrix
Version Model NumberDURS2291
Catalog NumberDURS2291
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
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.
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
GS110381780023500 [Primary]
HIBCCM269DURS22911 [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 [Suturable DuraGen™ Dural Regeneration Matrix]

10381780023524SUTURABLE DURAGEN, 1PK, 4x5 Suturable DuraGen™ Dural Regeneration Matrix is an absorbable impl
10381780023517SUTURABLE DURAGEN, 1PK, 3x3 Suturable DuraGen™ Dural Regeneration Matrix is an absorbable impl
10381780023500SUTURABLE DURAGEN, 1PK, 2x2 Suturable DuraGen™ Dural Regeneration Matrix is an absorbable impl
10381780023494SUTURABLE DURAGEN, 1PK, 1x3 Suturable DuraGen™ Dural Regeneration Matrix is an absorbable impl

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