Biodesign

Basic Information

• Brand Name: Biodesign
• Primary DI: 00827002310902
• Version / Model: G31090
• Catalog Number: C-DUR-4X7
• Company Name: COOK BIOTECH INCORPORATED
• Labeler DUNS: 945385862
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-11-03
• Public Version: 5
• Public Version Date: 2022-03-31
• Public Version Status: Update
• Public Device Record Key: 8c74750b-5368-4d19-9a40-e23fe108cb8e

Device Description

Biodesign Dural Graft

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
GXQ	DURA SUBSTITUTE	Neurology	882.5910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48155	Dura mater biomatrix implant	A bioabsorbable device made of animal-derived collagen (e.g., equine, porcine) designed to temporarily substitute for dura mater during surgical repair or replacement of dura, and to function as a matrix for the regeneration of living dura. Restoration of the dura mater maintains the integrity of the brain and spinal cord, and helps prevent leakage of the cerebrospinal fluid (CSF). The device is typically in the form of a transparent foil that usually requires no suturing and may be used with fibrin sealant.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002310902	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K031850	000
K160869	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in clean, dry location at controlled room temperature. Do not freeze.
• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius