Natus®

Basic Information

• Brand Name: Natus®
• Primary DI: 00382830055949
• Version / Model: NT955141
• Catalog Number: NT955141
• Company Name: NATUS MEDICAL INCORPORATED
• Labeler DUNS: 081325959
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-03
• Public Version: 1
• Public Version Date: 2020-04-13
• Public Version Status: New
• Public Device Record Key: d3262dfe-e24f-48eb-ae1e-dd6024c4031c

Device Description

BURR HOLE RESERVOIR AND SILICONE CAP WITH F8 SIDE ARM (Stainless Steel - Ø 10 mm - Depth 0.8 mm)

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: Yes
• MRI Safety: MR Conditional
• 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
61375	Cranial port/reservoir	A sterile, implantable chamber intended to be connected to an intracerebral catheter for infusion/injection of materials (e.g., chemotherapeutic agents, radioisotopes) into the brain (e.g., cerebral ventricles, cystic tumours, tumour cavities); it may also be used for drainage of cerebrospinal fluid (CSF) from the ventricles and as part of a ventriculo-peritoneal/atrial shunt system. The device is implanted subcutaneously and materials infused/injected with a needle via hypodermic puncture flow into the target site through the connected catheter. It is typically a bulb-shaped device made of plastic material (e.g., polypropylene, silicone). This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00382830055949	GS1
Previous	10381780034360	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K152897	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Shallow Reservoir 0.8mm Depth x 10mm Diam., Cap Side Arm 2.7mm O.D. x 1.4mm I.D. (F8)