eCoin External Controller Kit 1011-5436

GUDID 00860007896972

eCoin External Controller Kit

Valencia Technologies Corporation

Tibial nerve implantable incontinence-control electrical stimulation system

• Primary Device ID: 00860007896972
• NIH Device Record Key: 6a04c0d9-e18a-45c8-ae89-35ef549a4c95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eCoin External Controller Kit
• Version Model Number: 1011-5436
• Catalog Number: 1011-5436
• Company DUNS: 968538988
• Company Name: Valencia Technologies Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	00860007896972 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P200036

FDA Product Code

• QPT: Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-05
• Device Publish Date: 2023-04-27

On-Brand Devices [eCoin External Controller Kit]

• 00860007896910: eCoin External Controller Kit
• 00860007896972: eCoin External Controller Kit