Neuray®

Basic Information

• Brand Name: Neuray®
• Primary DI: 00763000032906
• Version / Model: 8004053
• Company Name: MEDTRONIC XOMED, INC.
• Labeler DUNS: 835465063
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-23
• Public Version: 2
• Public Version Date: 2021-11-01
• Public Version Status: Update
• Public Device Record Key: 230447da-00a6-4799-83f0-3666c60f4f4e
• Distribution End Date: 2020-02-05

Device Description

PACKING 8004053 NEURAY 200PK 25X152MM

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
38496	Radiopaque woven surgical sponge	A non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20763000032900	GS1	PK	200	Not in Commercial Distribution	2020-02-05
Primary	00763000032906	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K923027	000

Device Sizes

Type	Value	Unit	Text
Width	6.0	Inch
Width	152.0	Millimeter
Length	1.0	Inch
Length	25.0	Millimeter