Omnigraft™

Basic Information

• Brand Name: Omnigraft™
• Primary DI: 10381780125754
• Version / Model: DFU4041S
• Company Name: Integra Lifesciences Corporation
• Labeler DUNS: 083171244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-11
• Public Version: 8
• Public Version Date: 2023-05-15
• Public Version Status: Update
• Public Device Record Key: 87aa43d7-ff55-4492-bc48-dafc360a28ef

Device Description

Omnigraft™ Dermal Regeneration Matrix 4cm x4cm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MDD	Device, Dermal Replacement	Unknown		3
MGR	Dressing, wound and burn, interactive	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
45023	Collagen wound matrix dressing	A sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template 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 is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780125754	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P900033	053

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store Flat
• Type: Storage Environment Temperature
• Temperature Range: 36 – 86 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius