Omnigraft™

GUDID 10381780258872

Integra® Omnigraft™ Dermal Regeneration Matrix (Omnigraft) is an advanced bilayer matrix for dermal regeneration. The dermal replacement layer consists of a porous, three-dimensional matrix, comprised of bovine collagen and chondtroitin-6-sulfate (C6S) that is designed with a controlled porosity and defined degradation rate. The temporary epidermal layer is made of a thin polysiloxane (silicone) layer to provide immediate wound coverage and control moisture loss from the wound.

Integra Lifesciences Corporation

Collagen wound matrix dressing
Primary Device ID10381780258872
NIH Device Record Key304d900b-e863-4ec0-9581-72eee58823ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameOmnigraft™
Version Model NumberDFU25251
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 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
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 Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780258872 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MDDDEVICE, DERMAL REPLACEMENT

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-08-28
Device Publish Date2017-02-01

On-Brand Devices [Omnigraft™]

10381780258889Omnigraft Kit containing 2.5cm x2.5cm Integra® Omnigraft™ Dermal Regeneration Matrix and 1 d
10381780258872Integra® Omnigraft™ Dermal Regeneration Matrix (Omnigraft) is an advanced bilayer matrix for
10381780125792Omnigraft Kit containing 7cm x7cm Integra® Omnigraft™ Dermal Regeneration Matrix and 1 disp
10381780125785Integra® Omnigraft™ Dermal Regeneration Matrix (Omnigraft) is an advanced bilayer matrix for
10381780125754Omnigraft Kit containing 4cm x4cm Integra® Omnigraft™ Dermal Regeneration Matrix and 1 dispo
10381780125747Integra® Omnigraft™ Dermal Regeneration Matrix (Omnigraft) is an advanced bilayer matrix for

Trademark Results [Omnigraft]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OMNIGRAFT
OMNIGRAFT
86765343 5266593 Live/Registered
Integra LifeSciences Corporation
2015-09-23
OMNIGRAFT
OMNIGRAFT
86439750 5018496 Live/Registered
Integra LifeSciences Corporation
2014-10-30

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