INTEGRA Meshed Dermal Regeneration Template MDRT8101

GUDID M269MDRT81011

INTEGRA Meshed Dermal Regeneration Template 8in. x 10in. (20cm x 25cm), an Integra template available in a Meshed configuration, 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.

Integra Lifesciences Corporation

Collagen wound matrix dressing
Primary Device IDM269MDRT81011
NIH Device Record Key7149c408-5dc0-4183-a6bb-865ae102c649
Commercial Distribution StatusIn Commercial Distribution
Brand NameINTEGRA Meshed Dermal Regeneration Template
Version Model NumberMDRT8101
Catalog NumberMDRT8101
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

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Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store Flat
Handling Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 30 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780000655 [Primary]
HIBCCM269MDRT81011 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MGRDressing, Wound And Burn, Interactive

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 Date2014-09-05

On-Brand Devices [INTEGRA Meshed Dermal Regeneration Template]

M269MDRT81011INTEGRA Meshed Dermal Regeneration Template 8in. x 10in. (20cm x 25cm), an Integra template avai
M269MDRT41011INTEGRA Meshed Dermal Regeneration Template 4in. x 10in. (10cm x 25cm), an Integra template avai
M269MDRT40511INTEGRA Meshed Dermal Regeneration Template 4in. x 5in. (10cm x 12.5cm), an Integra template ava
M269MDRT20211INTEGRA Meshed Dermal Regeneration Template 2in. x 2in. (5cm x 5cm), an Integra template availab

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