DuraSeal®

Basic Information

• Brand Name: DuraSeal®
• Primary DI: 10381780000020
• Version / Model: 202050
• Catalog Number: 202050
• Company Name: Integra Lifesciences Corporation
• Labeler DUNS: 083171244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-29
• Public Version: 8
• Public Version Date: 2023-04-14
• Public Version Status: Update
• Public Device Record Key: 4c1f7157-c999-4ca1-84f4-bdf26086335c

Device Description

DuraSeal® Dural Sealant System 5mL 5 pack

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: 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
NQR	Sealant, Dural	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
47171	Dura mater sealant	An implanted bioabsorbable material (e.g., solution, gel, spray, patch) intended to be applied to a defect in the dura mater, possibly as an adjunct to standard methods of closure (e.g., suturing), to prevent cerebrospinal fluid (CSF) leakage during healing. The material primarily consists of synthetic polymers that subsequently form adhesive bonds with the dura mater and eventually degrade and are absorbed. After application, this device cannot be reused.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780000020	GS1
Package	30381780000024	GS1	BOX	5	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P040034	024

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Nominal inner volume content 5 Milliliter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 0 – 77 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 0 – 25 Degrees Celsius