Fortify Flowable

Basic Information

• Brand Name: Fortify Flowable
• Primary DI: 00827002590748
• Version / Model: G59074
• Catalog Number: FFM-01-KIT
• Company Name: COOK BIOTECH INCORPORATED
• Labeler DUNS: 945385862
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-02
• Public Version: 1
• Public Version Date: 2021-08-10
• Public Version Status: New
• Public Device Record Key: b135c54e-76b0-4c23-8596-d23cca13762f

Device Description

Fortify Flowable Extracellular Matrix

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
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	00827002590748	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K160136	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a clean, dry location at room temperature
• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius