FDA.reportPublic FDA data

Integra® Dermal Regeneration Template

Primary DI
10381780000617
Brand
Integra® Dermal Regeneration Template
Company
Integra Lifesciences Corporation
Model
38105
Catalog number
38105
Device description
INTEGRA Dermal Regeneration Template 8in. x 10in. (20cm x 25cm) 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
10381780000617PrimaryGS10
M269381051SecondaryHIBCC0
00381780000610Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038178000061710381780000617
00381780000610003817800006103817800006100381780000610

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
10381780272618Omni-Tract®11908119082018-02-23
20705031004334BioPatch™31502016-06-20
20705031004341BioPatch™31512016-06-20
20705031004358BioPatch™31522016-06-20
10381780541387Durepair®62105621052026-03-11
10381780541400Durepair®62110621102026-03-11
10381780541417Durepair®62111621112026-03-11
10381780541370Durepair®62100621002026-03-11
10381780541394Durepair®62106621062026-03-11
10381780541424Durepair®62158621582026-03-11
10381780537434Hermetic™ PlusINS8301INS83012024-06-28
10381780253549MAYFIELD®A1114A11142016-07-26
10381780253556MAYFIELD®A1114AA1114A2016-07-26
10381780268666Omni-Tract®3121R3121R2018-02-23
10381780269953Omni-Tract®3810R3810R2018-02-23
10381780270072Omni-Tract®3858R3858R2018-02-23
10381780270393Omni-Tract®392239222018-02-23
10381780374121AccuDrain®SP02202017-05-08
10381780542254MAYFIELD®A4000PA4000P2026-02-05
10381780542261MAYFIELD®A4000SRLA4000SRL2026-02-05

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
10381780000570Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMDD2014-09-05
10381780000570Integra® 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 CorporationMGR2014-09-05
10381780000594Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMDD2014-09-05
10381780000600Integra® Dermal Regeneration TemplateIntegra Lifesciences CorporationMDD2014-09-05
10381780000600Integra® 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