FDA.reportPublic FDA data

Omnigraft™

Primary DI
10381780125785
Brand
Omnigraft™
Company
Integra Lifesciences Corporation
Model
DFU7071
Catalog number
DFU7071
Device description
Omnigraft™ Dermal Regeneration Matrix (Omnigraft)
Published
2016-05-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDDDevice, Dermal Replacement
MGRDressing, wound and burn, interactive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDDDevice, Dermal ReplacementUnknown3
MGRDressing, Wound And Burn, InteractiveUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P900033042

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P900033042INTEGRA DERMAL REGENERATION TEMPLATEIntegra Lifesciences Corp.1996-03-01MGR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780125785PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178012578510381780125785

GMDN Terms#

Term, Definition table
TermDefinition
Collagen wound matrix dressingA sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store Flat
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature36 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
083171244
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780112075Integra OS™IOS10125IOS101252015-09-23
10381780112082Integra OS™IOS10155IOS101552015-09-23
10381780112426Trel-XC PasteTXCPA01TXCPA012015-09-22
10381780112433Trel-XC PasteTXCPA03TXCPA032015-09-22
10381780112440Trel-XC PasteTXCPA08TXCPA082015-09-22
10381780112457Trel-XC PuttyTXCPY05TXCPY052015-09-22
10381780112464Trel-XC PuttyTXCPY10TXCPY102015-09-22
10381780112471Trel-X PuttyTXP05TXP052015-09-22
10381780112488Trel-X PuttyTXP10TXP102015-09-22
10381780112495Trel-X GelTXG01TXG012015-09-22
10381780112501Trel-X GelTXG05TXG052015-09-22
10381780112518Trel X-Press 100XPRES110XPRES1102015-09-22
10381780112525Trel X-Press 100XPRES105XPRES1052015-09-22
10381780112532Trel X-Press 100XPRES125XPRES1252015-09-22
10381780112556Trel X-Press 300XPRES305XPRES3052015-09-25
10381780112563Trel X-Press 300XPRES325XPRES3252015-09-25
10381780112570Trel XPress 300CXPres3c10XPres3c102015-09-25
10381780114338Collage Osteoconductive Scaffold - Putty7100057100052015-09-22
10381780114345Collage Osteoconductive Scaffold - Putty7100107100102015-09-22
10381780114352Collage Osteoconductive Scaffold - Putty7100157100152015-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00618474000046TransCyteORGANOGENESIS INC.MGR2018-01-12
10381780258872Omnigraft™Integra Lifesciences CorporationMDD2017-02-01
10381780258872Omnigraft™Integra Lifesciences CorporationMGR2017-02-01
10381780258889Omnigraft™Integra Lifesciences CorporationMDD2017-02-01
10381780125747Omnigraft™Integra Lifesciences CorporationMDD2016-05-11
10381780125754Omnigraft™Integra Lifesciences CorporationMDD2016-05-11
10381780125792Omnigraft™Integra Lifesciences CorporationMDD2016-05-11
10381780000549Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMGR2014-09-05
10381780000549Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMDD2014-09-05
10381780000556Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMDD2014-09-05
10381780000556Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMGR2014-09-05
10381780000563Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMDD2014-09-05
10381780000563Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMGR2014-09-05
10381780000570Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMDD2014-09-05
10381780000570Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMGR2014-09-05
10381780000587Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMGR2014-09-05
10381780000587Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMDD2014-09-05
10381780000594Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMDD2014-09-05
10381780000594Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMGR2014-09-05
10381780000600Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMDD2014-09-05
10381780000600Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMGR2014-09-05
10381780000617Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMDD2014-09-05
10381780000617Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMGR2014-09-05
10381780000624Integra®Integra Lifesciences CorporationMGR2014-09-05
10381780000624Integra®Integra Lifesciences CorporationMDD2014-09-05
10381780000631Integra®Integra Lifesciences CorporationMDD2014-09-05
10381780000631Integra®Integra Lifesciences CorporationMGR2014-09-05
10381780000648Integra®Integra Lifesciences CorporationMDD2014-09-05
10381780000648Integra®Integra Lifesciences CorporationMGR2014-09-05
10381780000655Integra®Integra Lifesciences CorporationMDD2014-09-05