BACTISEAL®

Basic Information

• Brand Name: BACTISEAL®
• Primary DI: 10381780519034
• Version / Model: 823088
• Catalog Number: 82-3088
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-01
• Public Version: 7
• Public Version Date: 2023-04-14
• Public Version Status: Update
• Public Device Record Key: 575a101d-90e2-4a71-a0c9-67a2d300e243

Device Description

BEVC KIT BACTISEAL® Endoscopic Ventricular Catheter and Distal Catheter Kit

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
JXG	Shunt, central nervous system and components	Neurology	882.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61399	Intracerebral infusion/drainage catheter, short-term	A flexible tube intended to be surgically inserted through the skull for short-term (= 30 days) subdural access to the brain (e.g., cerebral ventricles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents); it may also be intended for measurement of intracranial pressure (ICP). It may include an attached port/reservoir at its proximal end that is placed subcutaneously to facilitate material infusion/collection, and/or accessory devices intended to facilitate catheter introduction and/or stabilization (e.g., stylet, bolts, drills, catheter holder); it does not include a sensor. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780519034	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K110751	000

Device Sizes

Type	Value	Unit	Text
Length	120	Centimeter
Length	14	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 36 – 81 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 2 – 27 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 2 – 27 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 36 – 81 Degrees Fahrenheit