SJM™

Basic Information

• Brand Name: SJM™
• Primary DI: 05415067017802
• Version / Model: 1121
• Catalog Number: 1121
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 149818952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-03-17
• Public Version: 4
• Public Version Date: 2023-08-01
• Public Version Status: Update
• Public Device Record Key: cdc182c7-08bf-4544-a49f-54c3e5594de1

Device Description

Stylet, Straight, 30 cm

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LGW	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
64578	Central nervous system electrical stimulation system lead stylet	A wire intended to be percutaneously inserted into the brain and/or epidural space to aid in the percutaneous placement of an implantable central nervous system (CNS) electrical stimulation system lead. It is manipulated proximally with the distal working end typically comprised of thin metal wire. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05415067017802	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P010032	000

Device Sizes

Type	Value	Unit	Text
Length	30	Centimeter

Storage Conditions

• 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: 70 – 150 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 150 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 14 – 131 Degrees Fahrenheit