Evoke® Closed-Loop Stimulator (CLS)

GUDID 09352307001565

SALUDA MEDICAL PTY LIMITED

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

• Primary Device ID: 09352307001565
• NIH Device Record Key: bc8709dd-c5dd-41cd-ba90-e41d8d740842
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Evoke® Closed-Loop Stimulator (CLS)
• Version Model Number: 3002
• Company DUNS: 744596461
• Company Name: SALUDA MEDICAL PTY LIMITED
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09352307001565 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P190002

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: 2023-10-18
• Device Publish Date: 2023-10-10

On-Brand Devices [Evoke® Closed-Loop Stimulator (CLS)]

• 09352307000292: 3002
• 09352307000759: 3042
• 09352307001572: 3042
• 09352307001565: 3002