Home GUDID 10381780125747 Omnigraft™
Primary DI 10381780125747
Brand Omnigraft™
Company Integra Lifesciences Corporation
Model DFU4041
Catalog number DFU4041
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 Product Codes# Code, Name table Code Name MDD Device, Dermal Replacement
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MDD Device, Dermal Replacement Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10381780125747 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10381780125747 10381780125747
GMDN Terms# Term, Definition table Term Definition Skin regeneration template, human-/animal-derived A sterile covering used as a temporary skin substitute on wounds (e.g., diabetic or venous insufficiency ulcers) or burns that involve the dermis, and that provides a matrix, typically 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 contains human- and animal-derived products (e.g., bovine, porcine), or only animal-derived products. It may be mono- or bi-layered, and may contain natural and synthetic materials. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Store Flat Storage Environment Temperature 2 Degrees Celsius 30 Degrees Celsius Storage Environment Temperature 36 Degrees Fahrenheit 86 Degrees Fahrenheit
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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10381780258872 Omnigraft™ Integra Lifesciences Corporation MDD 2017-02-01 10381780258889 Omnigraft™ Integra Lifesciences Corporation MDD 2017-02-01 10381780125754 Omnigraft™ Integra Lifesciences Corporation MDD 2016-05-11 10381780125785 Omnigraft™ Integra Lifesciences Corporation MDD 2016-05-11 10381780125792 Omnigraft™ Integra Lifesciences Corporation MDD 2016-05-11 10381780000549 Integra® Dermal Regeneration Template Integra Lifesciences Corporation MDD 2014-09-05 10381780000556 Integra® Dermal Regeneration Template Integra Lifesciences Corporation MDD 2014-09-05 10381780000563 Integra® Dermal Regeneration Template Integra Lifesciences Corporation MDD 2014-09-05 10381780000570 Integra® Dermal Regeneration Template Integra Lifesciences Corporation MDD 2014-09-05 10381780000587 Integra® Dermal Regeneration Template Integra Lifesciences Corporation MDD 2014-09-05 10381780000594 Integra® Dermal Regeneration Template Integra Lifesciences Corporation MDD 2014-09-05 10381780000600 Integra® Dermal Regeneration Template Integra Lifesciences Corporation MDD 2014-09-05 10381780000617 Integra® Dermal Regeneration Template Integra Lifesciences Corporation MDD 2014-09-05 10381780000624 Integra® Integra Lifesciences Corporation MDD 2014-09-05 10381780000631 Integra® Integra Lifesciences Corporation MDD 2014-09-05 10381780000648 Integra® Integra Lifesciences Corporation MDD 2014-09-05 10381780000655 Integra® Integra Lifesciences Corporation MDD 2014-09-05
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