SandShark Injectable Anchor System

GUDID 00859619004202

SandShark Injectable Anchor System

STIMWAVE TECHNOLOGIES INCORPORATED

Analgesic spinal cord electrical stimulation system

• Primary Device ID: 00859619004202
• NIH Device Record Key: 81778b87-f36e-47d8-90ce-31c37860071a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SandShark Injectable Anchor System
• Version Model Number: SHRK-ALL-1K
• Company DUNS: 078294927
• Company Name: STIMWAVE TECHNOLOGIES INCORPORATED
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• 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 Dimensions

• Weight: 0.25 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859619004202 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172644

FDA Product Code

• GZB: Stimulator, Spinal-Cord, Implanted (Pain Relief)

Sterilization

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

[00859619004202]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-05

On-Brand Devices [SandShark Injectable Anchor System]

• 00859619004202: SandShark Injectable Anchor System
• 00850051034222: SandShark Injectable Anchor System