Neuray

Basic Information

• Brand Name: Neuray
• Primary DI: 20681490171568
• Version / Model: 8004004
• Company Name: MEDTRONIC XOMED, INC.
• Labeler DUNS: 835465063
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2016-05-22
• Public Version: 4
• Public Version Date: 2023-08-29
• Public Version Status: Update
• Public Device Record Key: 232b6a50-5374-4a2f-a909-d33b9e3bceb0
• Distribution End Date: 2021-07-29

Device Description

PACKING 8004004 NEURAY 200PK 13X38MM

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
Primary	20681490171568	GS1
Unit of Use	00681490171564	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K923027	000

Device Sizes

Type	Value	Unit	Text
Width	13.0	Millimeter
Length	38.0	Millimeter