Evoke® Spares Kit

GUDID 09352307001695

SALUDA MEDICAL PTY LIMITED

Neurosurgical procedure kit, non-medicated, single-use

• Primary Device ID: 09352307001695
• NIH Device Record Key: 5d649390-2a61-48b0-92ac-2456378a9b0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Evoke® Spares Kit
• Version Model Number: 3015
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09352307001695 [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® Spares Kit ]

• 09352307000179: 3015
• 09352307001688: 3015
• 09352307000827: 3015
• 09352307001701: 3015
• 09352307001695: 3015