DuraGen Plus™ Spinal Matrix 51100213

GUDID 10381780070726

DuraGen Plus Dural Regeneration Matrix- Spinal Matrix is an absorbable implant for repair of dural defects. DuraGen Plus Dural Regeneration Matrix-Spinal Matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen Plus Dural Regeneration Matrix-Spinal Matrix is two 1 inch x 3 inch (2.5cm x 7.5xm) dural regeneration matrices supplied sterile, non-pyrogenic, for single use in double peel packages.

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
Primary Device ID10381780070726
NIH Device Record Key7fc71b32-47dd-4305-a16c-09e5b49fca8a
Commercial Distribution Discontinuation2015-09-24
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDuraGen Plus™ Spinal Matrix
Version Model Number51100213
Catalog Number51100213
Company DUNS083171244
Company NameIntegra Lifesciences Corporation
Device Count2
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 Latextrue
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

Device Dimensions

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Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100381780070729 [Unit of Use]
GS110381780070726 [Primary]
HIBCCM269511002131 [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 Number5
Public Version Date2020-09-22
Device Publish Date2015-09-22

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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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