SJM™ 1122

GUDID 05415067019455

ST. JUDE MEDICAL, INC.

Catheter stylet

• Primary Device ID: 05415067019455
• NIH Device Record Key: 40149fa8-9e9b-41f6-843d-ccb715053afb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SJM™
• Version Model Number: 1122
• Catalog Number: 1122
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter
• Length: 30 Centimeter

Operating and Storage Conditions

• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT EXPOSE TO LIQUIDS OR EXCESSIVE MOISTURE
• Handling Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Storage Environment Temperature: Between -10 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 150 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067019455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010032

FDA Product Code

• LGW: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-03-17

On-Brand Devices [SJM™]

• 05415067027764: Monitor Cable
• 05415067027238: Connector Cable Kit
• 05415067025258: REUSABLE RF ELECTRODE
• 05415067025241: REUSABLE RF ELECTRODE
• 05415067025234: REUSABLE RF ELECTRODE
• 05415067025227: REUSABLE RF ELECTRODE
• 05415067025210: REUSABLE NITINOL RF ELECTRODE
• 05415067025203: REUSABLE NITINOL RF ELECTRODE
• 05415067025197: REUSABLE NITINOL RF ELECTRODE
• 05415067025180: REUSABLE NITINOL RF ELECTRODE
• 15415067024067: 1105
• 05415067024015: Multilead Trial Cable
• 05415067023681: 3875
• 05415067023674: 3874
• 05415067023667: DBS External Pulse Generator, 16 Channel
• 05415067023384: PW USB Receiver
• 05415067023377: AO USB Receiver
• 05415067021120: 3853
• 15415067021042: 405428
• 15415067021035: 405422
• 15415067021028: 405418
• 15415067021011: 405404
• 15415067021004: 405270
• 15415067020977: 405129
• 15415067020960: 405128
• 15415067020953: 405124
• 15415067020946: 405122
• 15415067020939: 405120
• 15415067020915: Peel Away Introducer
• 05415067019516: 1701
• 05415067019493: 1108
• 05415067019462: 1122
• 05415067019455: 1122
• 05415067019424: 1106
• 05415067018854: Nonadhesive Pouch with Belt, EPG
• 05415067018533: Adhesive Pouch, EPG
• 05415067018038: Power Supply
• 05415067017918: 3383
• 05415067017864: Epideral Needle
• 05415067017857: 1124
• 05415067017826: 1126
• 05415067017819: 1125
• 05415067017802: 1121
• 05415067017109: 1254
• 05415067016713: 2321
• 05415067016706: 2311
• 05415067016690: 2326
• 05415067016683: 2316
• 05415067016560: 3032
• 05415067016553: 3599