SJM™

Basic Information

• Brand Name: SJM™
• Primary DI: 05414734405355
• Version / Model: 3013
• Catalog Number: 3013
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 149818952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-04-25
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 18d2cfb1-3b37-469e-848b-ea8fa683bd3e

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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GZB	STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)	Neurology	882.5880	2
GZF	STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)	Neurology	882.5870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48054	Neural-tissue electrical stimulation lead adaptor	A sterile implantable device intended to provide a functional and modified connection between existing neurostimulation leads and an implanted replacement neurostimulator [e.g., a spinal cord stimulation (SCS) or a deep brain stimulation (DBS) stimulator]. It typically consists of a small connector block to enable attachment to the existing stimulation leads (i.e., when they do not meet connection design) and connection to the replacement neurostimulator. During implantation the surgeon uses a tool to tighten the connections (e.g., a Hex wrench), and a medical adhesive to seal the connections from body fluid contamination.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05414734405355	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K130545	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 14 – 131 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 14 – 131 Degrees Fahrenheit
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal