Natus

Basic Information

• Brand Name: Natus
• Primary DI: 40382830062334
• Version / Model: HITHRZRX
• Company Name: NATUS MEDICAL INCORPORATED
• Labeler DUNS: 081325959
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2023-05-04
• Public Version: 1
• Public Version Date: 2023-05-12
• Public Version Status: New
• Public Device Record Key: f805661c-0262-4138-ad81-2c461acc9be3

Device Description

CRANIAL ACCESS KIT

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
PVM	Endoscopic Ventricular Catheter Placement Kit	Neurology	882.4100	2
PSP	Intracranial Pressure & Temperature Monitoring Kit	Neurology	882.1620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44064	Neurosurgical procedure kit, medicated	A collection of various sterile neurosurgical instruments, dressings, pharmaceuticals, and the necessary materials used to perform a neurosurgical procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10382830062333	GS1
Primary	40382830062334	GS1