Hermetic™ II

Basic Information

• Brand Name: Hermetic™ II
• Primary DI: 10381780071655
• Version / Model: NL8508305N
• Catalog Number: NL8508305N
• Company Name: Integra Lifesciences Corporation
• Labeler DUNS: 083171244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-22
• Public Version: 6
• Public Version Date: 2023-05-16
• Public Version Status: Update
• Public Device Record Key: 5705ab2b-0455-4ea0-a277-e7e09facd310

Device Description

Hermetic™ II External CSF Drainage Management Replacement Collection Bag

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
JXG	Shunt, central nervous system and components	Neurology	882.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61797	Lumbar cerebrospinal fluid drainage catheterization kit	A collection of sterile devices intended for short-term percutaneous access to the subarachnoid (intrathecal) or epidural space of the lumbar spinal column to drain cerebrospinal fluid (CSF), and/or other fluids of similar physical characteristics, as a means of reducing CSF volume and intracranial pressure (ICP). It includes a spinal infusion/drainage catheter and devices intended for catheter insertion (e.g. Tuohy needle, suture, guidewire) and CSF collection (e.g., drip chamber, drainage bag, tubing set, filter). This is a single-use device.	No	Active
61798	Ventricular cerebrospinal fluid drainage catheterization kit	A collection of sterile devices intended for short-term access to the brain ventricles to drain cerebrospinal fluid (CSF), and/or other fluids of similar physical characteristics, as a means of reducing CSF volume and intracranial pressure (ICP). It includes an intracerebral infusion/drainage catheter and devices intended for catheter insertion (e.g. stylet) and CSF collection (e.g., drip chamber, drainage bag, tubing set). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30381780071659	GS1	BOX	5	In Commercial Distribution
Primary	10381780071655	GS1
Secondary	M269NL8508305N1	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K864676	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			700 ml