NA

Basic Information

• Brand Name: NA
• Primary DI: 05415067047670
• Version / Model: 66000
• Catalog Number: 66000
• Company Name: ADVANCED NEUROMODULATION SYSTEMS, INC.
• Labeler DUNS: 021675699
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-16
• Public Version: 1
• Public Version Date: 2024-02-26
• Public Version Status: New
• Public Device Record Key: 07e87429-a5f1-4653-93be-e40da430f010

Device Description

Charger Kit, Pectoral

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PJS	Stimulator, electrical, implanted, for essential tremor	Unknown		3
MHY	Stimulator, electrical, implanted, for parkinsonian tremor	Unknown		3
NHL	Stimulator, electrical, implanted, for parkinsonian symptoms	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
33658	Implant battery charger	An electronic device intended to be used to wirelessly recharge the batteries of an active implantable device in situ. It is not intended to program or extract data from (read) the implanted device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05415067047670	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P140009	087

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Excursions from -20C to 60C. Long Term Storage Temperature 23C (73F)