Integra

Basic Information

• Brand Name: Integra
• Primary DI: 10381780032472
• Version / Model: FWD301
• Catalog Number: FWD301
• Company Name: Integra Lifesciences Corporation
• Labeler DUNS: 083171244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-23
• Public Version: 9
• Public Version Date: 2023-05-16
• Public Version Status: Update
• Public Device Record Key: 94f2b815-3ff5-4a2f-9f6d-ca7ff4abc8ce

Device Description

INTEGRA Flowable Wound Matrix

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: No
• 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
KGN	DRESSING, WOUND, COLLAGEN	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
46975	Wound protein matrix solution	A viscous, proteinaceous substance that is topically applied to a wound bed to provide a temporary (degradable) matrix of structural proteins (animal-derived) for the attachment of native cells, to promote wound healing. It is typically contained within a syringe and applied with an applicator. It is intended as a primary dressing typically for hard-to-heal ulcers (e.g., venous leg ulcers), and is covered with a secondary dressing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M269FWD3011	HIBCC
Primary	10381780032472	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K072113	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			3 cc

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius