Omnigraft™
GUDID 10381780125747
Integra® Omnigraft™ Dermal Regeneration Matrix (Omnigraft) is an advanced bilayer matrix for dermal regeneration. The dermal replacement layer consists of a porous, three-dimensional matrix, comprised of bovine collagen and chondtroitin-6-sulfate (C6S) that is designed with a controlled porosity and defined degradation rate. The temporary epidermal layer is made of a thin polysiloxane (silicone) layer to provide immediate wound coverage and control moisture loss from the wound.
Integra Lifesciences Corporation
Skin regeneration template, human-/animal-derived Skin regeneration template, human-/animal-derived Skin regeneration template, human-/animal-derived Skin regeneration template, human-/animal-derived Skin regeneration template, human-/animal-derived Skin regeneration template, human-/animal-derived Skin regeneration template, human-/animal-derived Skin regeneration template, human-/animal-derived Skin regeneration template, human-/animal-derived Skin regeneration template, human-/animal-derived Skin regeneration template, human-/animal-derived Skin regeneration template, human-/animal-derived Skin regeneration template, human-/animal-derived Skin regeneration template, human-/animal-derived Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing| Primary Device ID | 10381780125747 |
| NIH Device Record Key | c4070ce0-8da8-4ec9-b332-5aed146b199b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Omnigraft™ |
| Version Model Number | DFU4041 |
| Company DUNS | 083171244 |
| Company Name | Integra Lifesciences Corporation |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
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Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Flat |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10381780125747 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P900033
FDA Product Code
| MDD | Device, Dermal Replacement |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-09-22 |
| Device Publish Date | 2016-05-11 |
On-Brand Devices [Omnigraft™]
| 10381780258889 | Omnigraft Kit containing 2.5cm x2.5cm Integra® Omnigraft™ Dermal Regeneration Matrix and 1 d |
| 10381780258872 | Integra® Omnigraft™ Dermal Regeneration Matrix (Omnigraft) is an advanced bilayer matrix for |
| 10381780125792 | Omnigraft Kit containing 7cm x7cm Integra® Omnigraft™ Dermal Regeneration Matrix and 1 disp |
| 10381780125785 | Integra® Omnigraft™ Dermal Regeneration Matrix (Omnigraft) is an advanced bilayer matrix for |
| 10381780125754 | Omnigraft Kit containing 4cm x4cm Integra® Omnigraft™ Dermal Regeneration Matrix and 1 dispo |
| 10381780125747 | Integra® Omnigraft™ Dermal Regeneration Matrix (Omnigraft) is an advanced bilayer matrix for |
Trademark Results [Omnigraft]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OMNIGRAFT 86765343 5266593 Live/Registered |
Integra LifeSciences Corporation 2015-09-23 |
 OMNIGRAFT 86439750 5018496 Live/Registered |
Integra LifeSciences Corporation 2014-10-30 |
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