NA

Basic Information

• Brand Name: NA
• Primary DI: 00643169298651
• Version / Model: 1352415
• Company Name: MEDTRONIC XOMED, INC.
• Labeler DUNS: 835465063
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-07
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 8e0e0373-4120-400d-bbcd-da895e5b81c3

Device Description

CABLE 1352415 STIM DISSECTION 3M ROHS

Device Characteristics

• Single Use: No
• 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: Yes
• 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: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ETN	STIMULATOR, NERVE	Ear, Nose, Throat	874.1820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35751	Transcutaneous electrical stimulation lead	A non-sterile, insulated, electrical conducting wire intended to be used to connect a transcutaneous electrical stimulation electrode to an electrical stimulus generator (e.g., TENS system generator), or a wire having a distal end that splits and terminates as electrodes which are placed on the patient for the transmission of electrical stimulation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00643169298651	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	3.0	Meter