Biodesign

Basic Information

• Brand Name: Biodesign
• Primary DI: 00827002542006
• Version / Model: G54200
• Catalog Number: C-FP-0.2
• Company Name: COOK BIOTECH INCORPORATED
• Labeler DUNS: 945385862
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-27
• Public Version: 3
• Public Version Date: 2025-02-19
• Public Version Status: Update
• Public Device Record Key: d9623706-e964-43f1-9ab8-42655acdd30d

Device Description

Biodesign Fistula Plug

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: 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
FTM	Mesh, surgical	General, Plastic Surgery	878.3300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62447	Fistula-repair biomatrix implant	A bioabsorbable, animal-derived substance intended to be implanted into a fistula tract (e.g., anal or rectal fistula) to close it by adding volume and promoting the ingrowth and neovascularization of host tissue. It consists primarily of an animal-derived matrix structure (e.g., made of collagen) that provides a scaffold for cell migration and growth, and which is gradually incorporated into and remodelled by host tissue. The material is typically preloaded in a disposable syringe.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10827002542003	GS1	BX	1	In Commercial Distribution
Primary	00827002542006	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K062729	000
K170016	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a clean place at room temperature. Do not place in freezer. Avoid excessive heat. Keep dry.