Eterna™ 32400

GUDID 05415067040763

Implantable Pulse Generator

ST. JUDE MEDICAL, INC.

Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

• Primary Device ID: 05415067040763
• NIH Device Record Key: e47c0341-779b-4602-9452-bf2ccdc10f9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eterna™
• Version Model Number: 32400
• Catalog Number: 32400
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 23 Degrees Celsius and 23 Degrees Celsius
• Handling Environment Temperature: Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 73 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Handling Environment Temperature: Between 23 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Excursion Temperature Limits: -20°C (-4°F) to 60°C to (140°F) Temperature Excursions: Excursions below 15°C (59°F) or above 30°C (86°F) should be < 24 hours in duration

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067040763 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-01-12
• Device Publish Date: 2023-01-04

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