FDA.reportPublic FDA data

Integra® Dermal Regeneration Template

Primary DI
10381780000570
Brand
Integra® Dermal Regeneration Template
Company
Integra Lifesciences Corporation
Model
34055
Catalog number
34055
Device description
INTEGRA Dermal Regeneration Template 4in. x 5in. (10cm x 12.5cm) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and a glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound.
Published
2014-09-05
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
P900033011

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P900033011INTEGRA DERMAL REGENERATION TEMPLATEIntegra Lifesciences Corp.1996-03-01MGR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780000570PrimaryGS10
M269340551SecondaryHIBCC0
00381780000573Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178000057010381780000570
00381780000573003817800005733817800005730381780000573

GMDN Terms#

Term, Definition table
TermDefinition
Animal-derived wound matrix dressingA bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. 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
Handling Environment Temperature2 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify00Store Flat

Contacts#

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

Regulatory Flags#

DUNS number
083171244
Device count
5
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
10381780125785Omnigraft™Integra Lifesciences CorporationMDD2016-05-11
10381780125785Omnigraft™Integra Lifesciences CorporationMGR2016-05-11
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
10381780000587Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMDD2014-09-05
10381780000587Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMGR2014-09-05
10381780000594Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMDD2014-09-05
10381780000594Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMGR2014-09-05
10381780000600Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMGR2014-09-05
10381780000600Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMDD2014-09-05
10381780000617Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMDD2014-09-05
10381780000617Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMGR2014-09-05
10381780000624Integra®Integra Lifesciences CorporationMDD2014-09-05
10381780000624Integra®Integra Lifesciences CorporationMGR2014-09-05
10381780000631Integra®Integra Lifesciences CorporationMDD2014-09-05
10381780000631Integra®Integra Lifesciences CorporationMGR2014-09-05
10381780000648Integra®Integra Lifesciences CorporationMGR2014-09-05
10381780000648Integra®Integra Lifesciences CorporationMDD2014-09-05
10381780000655Integra®Integra Lifesciences CorporationMGR2014-09-05