Neuray®

Basic Information

• Brand Name: Neuray®
• Primary DI: 00763000032807
• Version / Model: 8004002
• Company Name: MEDTRONIC XOMED, INC.
• Labeler DUNS: 835465063
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-17
• Public Version: 1
• Public Version Date: 2019-03-25
• Public Version Status: New
• Public Device Record Key: e5bf3bdb-ded9-41cd-8cc5-7642deaeaabe

Device Description

PACKING 8004002 NEURAY 200PK 13X25MM

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HBA	NEUROSURGICAL PADDIE	Neurology	882.4700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32572	Cottonoid pad	A cushion-like mass made of cotton or man-made fibres used during surgery (e.g., neurosurgery) to protect tissue, absorb fluids, and/or stop bleeding. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20763000032801	GS1	PK	200	In Commercial Distribution
Primary	00763000032807	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K923027	000

Device Sizes

Type	Value	Unit	Text
Length	13.0	Millimeter
Length	0.5	Inch
Width	25.0	Millimeter
Width	1.0	Inch